Azpipeline_org

(STEM) Science, Technology, Engineering & Mathematics

Biostatisticians

Develop and apply biostatistical theory and methods to the study of life sciences.

Salary Breakdown

Biostatisticians

Average

$74,480

ANNUAL

$35.81

HOURLY

Entry Level

$55,990

ANNUAL

$26.92

HOURLY

Mid Level

$73,615

ANNUAL

$35.40

HOURLY

Expert Level

$91,240

ANNUAL

$43.87

HOURLY


Current Available & Projected Jobs

Biostatisticians

23

Current Available Jobs

870

Projected job openings through 2024


Sample Career Roadmap

Biostatisticians


Top Expected Tasks

Biostatisticians


Knowledge, Skills & Abilities

Biostatisticians

Common knowledge, skills & abilities needed to get a foot in the door.

KNOWLEDGE

Mathematics

KNOWLEDGE

English Language

KNOWLEDGE

Computers and Electronics

KNOWLEDGE

Education and Training

KNOWLEDGE

Medicine and Dentistry

SKILL

Mathematics

SKILL

Reading Comprehension

SKILL

Critical Thinking

SKILL

Complex Problem Solving

SKILL

Science

ABILITY

Mathematical Reasoning

ABILITY

Written Comprehension

ABILITY

Deductive Reasoning

ABILITY

Inductive Reasoning

ABILITY

Oral Comprehension


Job Opportunities

Biostatisticians

  • Sr Lead Research Associate
    RR Donnelley    Phoenix, AZ 85067
     Posted 6 days    

    The Senior Research Associate position was created for individuals who are interested in enhancing their knowledge set and working in a fast-paced environment. The Senior Research Associate's primary responsibility is to utilize centralized research resources/databases to provideresearch in support of the firm’s Investment Banking division and other departments. The Senior Research Associate will work on researchprojects and ad hoc global projects. The position will cover Special Situations and Macroeconomic Research and will potentially be aligned withother sectors. The ideal candidate will have done work of a similar nature in the past and have experience leading a team and managingprojects.

    Research Responsibilities:● Provide value-added, consistently accurate, targeted and timely third-party research on industries and markets to support strategicfinancial decisions● Perform macroeconomic research to support the creation of pitch books and company/industry reports● Additional tasks include:o Conduct news runs on a specific industry or topic● Knowledge management: utilization of tools including Jive, Microsoft SharePoint and email forums● Accurately record resource and time utilization metrics as well as tracking and reporting of team metrics and performance indicators● Maintain a heightened awareness of compliance and client confidentiality obligations● Advise client business units on the cost of information in order to assist in managing research spend

    Requirements:● Possess strong knowledge and understanding of secondary research sources for quantitative and qualitative industry information;within economics and other sectors a plus● Industry research experience at a financial services, corporate / research libraries, consulting or professional services firms● Effective time and project management skills to effectively coordinate team workflows and ensure high productivity● Aptitude and enthusiasm to collaborate with Global / virtual teams to deliver comprehensive client solutions● Refined written and oral communication skills to provide fluidity across working relationships● Strong work ethic, proactive, enthusiastic attitude, and eager team contributor● Flexible approach to duties and hours of work● Technology literate (e.g. MS Office Suite, Skype, Zoom, etc.)

    Experience:● 3-4 years of experience in an information management, competitive intelligence or sector research role● Undergraduate or Graduate degree in Library and Information Science, a plus● Leadership of a successful team in a professional environment● Working with financial services and related organizations including brokerage firms, consulting agencies, third party research outfits,investment banks, market research companies, private equity firms, corporate finance firms, etc.

    Database/Research skills● Exposure to any of the following data sources:IHS | Euromonitor| IBISWorld| Statista | Fitch Solutions | Industry Associations | Consulting Agencies | Google Scholar | OtherSecondary Market Research Agencies

    Shift: Mon- Fri ; 10:00am - 7:00pm

    RRD is an EEO/AA including Vets and Disabled Employer

    Required SkillsRequired Experience


    Employment Type

    Full Time

  • Senior Research Associate
    RR Donnelley    Phoenix, AZ 85067
     Posted 6 days    

    At RRD, our people make a difference every day – in production, working with customers, or behind the scenes in a support role. They know how to manage the job and exceed expectations. Founded 157 years ago RRD is a Fortune 500 company that employs approximately 43,000 people in 34 countries across the globe. For a challenging and rewarding career opportunity with an innovative industry leader, consider starting or continuing your career with RRD!

    The Senior Research Associate position was created for individuals who are interested in enhancing their knowledge set and working in a fast-paced environment. The Senior Research Associate's primary responsibility is to utilize centralized research resources/databases to provide research in support of the firm’s Investment Banking division and other departments. The Senior Research Associate will work on research projects and ad hoc global projects. The position will cover Special Situations and Macroeconomic Research and will potentially be aligned with other sectors.

    Research Responsibilities:

    + Provide value-added, consistently accurate, targeted and timely third-party research on industries and markets to support strategic financial decisions

    + Perform macroeconomic research to support the creation of pitch books and company/industry reports

    + Additional tasks include:

    + Conduct news runs on a specific industry or topic

    + Knowledge management: utilization of tools including Jive, Microsoft SharePoint and email forums

    + Accurately record resource and time utilization metrics as well as tracking and reporting of team metrics and performance indicators

    + Maintain a heightened awareness of compliance and client confidentiality obligations

    + Advise client business units on the cost of information in order to assist in managing research spend

    Requirements:

    + Possess strong knowledge and understanding of secondary research sources for quantitative and qualitative industry information; within economics and other sectors a plus

    + Industry research experience at a financial services, corporate / research libraries, consulting or professional services firms

    + Effective time and project management skills to effectively coordination of team workflows and ensure high productivity

    + Aptitude and enthusiasm to collaborate with Global / virtual teams to deliver comprehensive client solutions

    + Refined written and oral communication skills to provide fluidity across working relationships

    + Strong work ethic, proactive, enthusiastic attitude, and eager team contributor

    + Flexible approach to duties and hours of work

    + Technology literate (e.g. MS Office Suite, Skype, Zoom, etc.)

    Experience:

    + 3-4 years of experience in an information management, competitive intelligence or sector research role

    + Awareness of and adept use of public information and proficiency with multiple proprietary third-party tools and databases

    + Undergraduate or Graduate degree in Library and Information Science, a plus

    + Working with financial services and related organizations including brokerage firms, consulting agencies, third party research outfits, investment banks, market research companies, private equity firms, corporate finance firms, etc.

    Database/Research skills

    + Exposure to any of the following data sources:

    IHS | Euromonitor| IBISWorld| Statista | Fitch Solutions | Industry Associations | Consulting Agencies | Google Scholar | Other Secondary Market Research Agencies

    Available Shifts:

    Monday-Friday 7:00am-3:00pm

    Monday-Friday 3:00pm-11:00pm

    RRD is an EEO/AA including Vets and Disabled Employer

    Required SkillsRequired Experience


    Employment Type

    Full Time

  • Senior Research Associate
    RR Donnelley    Phoenix, AZ 85067
     Posted 6 days    

    At RRD, our people make a difference every day – in production, working with customers, or behind the scenes in a support role. They know how to manage the job and exceed expectations. Founded 157 years ago RRD is a Fortune 500 company that employs approximately 43,000 people in 34 countries across the globe. For a challenging and rewarding career opportunity with an innovative industry leader, consider starting or continuing your career with RRD!

    The Senior Research Associate position was created for individuals who are interested in enhancing their knowledge set and working in a fast-paced environment. The Senior Research Associate's primary responsibility is to utilize centralized research resources/databases to provide research in support of the firm’s Investment Banking division and other departments. The Senior Research Associate will work on research projects and ad hoc global projects. The position will cover Special Situations and Macroeconomic Research and will potentially be aligned with other sectors.

    Research Responsibilities:

    + Provide value-added, consistently accurate, targeted and timely third-party research on industries and markets to support strategic financial decisions

    + Perform macroeconomic research to support the creation of pitch books and company/industry reports

    + Additional tasks include:

    + Conduct news runs on a specific industry or topic

    + Knowledge management: utilization of tools including Jive, Microsoft SharePoint and email forums

    + Accurately record resource and time utilization metrics as well as tracking and reporting of team metrics and performance indicators

    + Maintain a heightened awareness of compliance and client confidentiality obligations

    + Advise client business units on the cost of information in order to assist in managing research spend

    Requirements:

    + Possess strong knowledge and understanding of secondary research sources for quantitative and qualitative industry information; within economics and other sectors a plus

    + Industry research experience at a financial services, corporate / research libraries, consulting or professional services firms

    + Effective time and project management skills to effectively coordination of team workflows and ensure high productivity

    + Aptitude and enthusiasm to collaborate with Global / virtual teams to deliver comprehensive client solutions

    + Refined written and oral communication skills to provide fluidity across working relationships

    + Strong work ethic, proactive, enthusiastic attitude, and eager team contributor

    + Flexible approach to duties and hours of work

    + Technology literate (e.g. MS Office Suite, Skype, Zoom, etc.)

    Experience:

    + 3-4 years of experience in an information management, competitive intelligence or sector research role

    + Awareness of and adept use of public information and proficiency with multiple proprietary third-party tools and databases

    + Undergraduate or Graduate degree in Library and Information Science, a plus

    + Working with financial services and related organizations including brokerage firms, consulting agencies, third party research outfits, investment banks, market research companies, private equity firms, corporate finance firms, etc.

    Database/Research skills

    + Exposure to any of the following data sources:

    IHS | Euromonitor| IBISWorld| Statista | Fitch Solutions | Industry Associations | Consulting Agencies | Google Scholar | Other Secondary Market Research Agencies

    Available Shifts:

    Monday-Friday 7:00am-3:00pm

    RRD is an EEO/AA including Vets and Disabled Employer

    Required SkillsRequired Experience


    Employment Type

    Full Time

  • Contract Sr Clinical Research Associate, Internal Medicine, Home-Based WEST USA, IQVIA Biotech
    IQVIA    Phoenix, AZ 85067
     Posted 7 days    

    **IQVIA Biotech is seeking a Contract CRA based in the WESTERN USA region.**

    + **2 years Field Monitoring experience required**

    + **Preferred experience in Allergy, Immunology, or Rare Disease.**

    + **This is a .3 FTE assignment**

    **BASIC FUNCTIONS:**

    Participates in the preparation and execution of Phase I-IV clinical trials. Oversees the progress of clinical investigations by conducting site evaluation, initiation, and interim close out visits to sites. Monitors clinical trials in accordance with Good Clinical Practices and procedures set forth by IQVIA Biotech and sponsors. Works closely with the Clinical Trial Manager (CTM) and/or Lead CRA t0 ensure all monitoring activities are conducted according to study requirements. The Senior CRA may also serve in the Lead CRA role.

    **ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:**

    + Participates in the investigator recruitment process. Performs site evaluation visits of potential investigators. Evaluates the capability of the site to successfully manage and conduct the clinical study.

    + Collaborates with the ISS department to coordinate activities with the site in preparation for the initiation of the study. Obtains regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials. Works with ISS and site staff to obtain regulatory (IRB/IEC) approval of study specific documents

    + Performs study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF; monitoring activities and study close-out activities.

    + Trains site staff on the EDC system and verifies site computer system.

    + Assists in resolving any issues to ensure compliance with site file audits in conjunction with ISS.

    + Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Performs validation of source documentation as required by sponsor. Prepares monitoring reports and letters per the timelines defined in IQVIA Biotech SOPs by using approved IQVIA Biotech/sponsor templates and reports.

    + Documents accountability, stability and storage conditions of clinical trial materials as required by sponsor. Performs investigational product inventory. Ensures return of unused materials to designated location or verifies destruction as required.

    + Reviews the quality and integrity of the clinical data through (1) in house review of electronic CRF data and (2) on-site source verification. Works with sites to resolve data queries.

    + May review protocols, eCRFs, study manuals and other related documents, as requested by the Clinical Trial Manager and/or Lead CRA.

    + Serves as primary contact between IQVIA Biotech and investigator; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested.

    + Performs study close-out visits per the study specific Clinical Monitoring Plan including final investigational product reconciliation and disposition, site study file reconciliation, data query resolution through to database lock and resolution of outstanding action items.

    + Assists with, and attends, Investigator Meetings for assigned studies.

    + Authorized to request site audits due to data integrity concerns.

    + Attends study-related, company, departmental, and external meetings, as required.

    + Ensures internal and study-related trainings are completed per IQVIA Biotech and/or study timelines; CTMS should always be current with the pertinent site updates/contacts.

    + Ensures all study deliverables are completed per IQVIA Biotech and study timelines

    + Conducts Field Evaluation Visits and field training of CRA Is, IIs and other Sr. CRAs.

    + Serves as mentor for junior CRAs and those new to the company and/or study.

    + Performs other duties, as requested.

    **LEAD CRA ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:**

    The Lead Clinical Research Associate **may** perform any of the following tasks:

    + Participate in the investigator recruitment process. Perform site evaluation visits, as needed, of potential investigators. Evaluates the capability of the site to successfully manage and conduct the clinical study.

    + Collaborate with the ISS department to coordinate activities with the site in preparation for the initiation of the study. Obtains regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials. Works with ISS and site staff to obtain regulatory (IRB/IEC) approval of study specific documents

    + Perform study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF; monitoring activities and study close-out activities.

    + Assists with, and attends, Investigator Meetings for assigned studies.

    + Train site staff on the EDC system and verify site computer system.

    + Assist in resolving any issues to ensure compliance with site file audits in conjunction with ISS.

    + Assure adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Performs validation of source documentation as required by sponsor. Prepares monitoring reports and letters per the timelines defined in IQVIA Biotech SOPs by using approved IQVIA Biotech/sponsor templates and reports.

    + Document accountability, stability and storage conditions of clinical trial materials as required by sponsor. Performs investigational product inventory. Ensures return of unused materials to designated location or verifies destruction as required.

    + Review the quality and integrity of the clinical data through (1) in house review of electronic CRF data and (2) on-site source verification. Work with sites to resolve data queries.

    + May review draft protocols, eCRFs, monitoring reports and follow-up letters, study manuals and other prepare study-related documents and templates, as requested by the CTM and/or PM.

    + May serve as primary contact between IQVIA Biotech and investigator; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested.

    + Assist CTM and/or PM in review of project budgets, monitoring costs, potential overruns and propose/implement cost effective solutions.

    + Assist the study management in identifying and generating changes in scope

    + Perform study close-out visits per the study specific Clinical Monitoring Plan including final investigational product reconciliation and disposition, site study file reconciliation, data query resolution through to database lock and resolution of outstanding action items.

    + Authorized to request site audits due to data integrity concerns.

    + Attends study-related, company, departmental, and external meetings, as required.

    + Ensure internal and study-related trainings are completed per IQVIA Biotech and/or study timelines; CTMS should always be current with the pertinent site updates/contacts.

    + Ensure all study deliverables are completed per IQVIA Biotech and study timelines

    + May conduct Field Evaluation Visits and field training of CRA Is, IIs and Sr CRAs.

    + Serve as mentor for junior CRAs and those new to the company and/or study.

    + Participate in the performance appraisal program by providing timely and accurate feedback regarding the performance of a perspective CRA.

    + Review and approve CRA travel expenses and time sheets.

    + Perform other duties, as requested.

    **KNOWLEDGE, SKILLS AND ABILITIES:**

    + Strong knowledge of clinical research process, including working knowledge of all functional areas of clinical trials and medical terminology.

    + Four+ years of oncology experience and/or medical device.

    + Experience in monitoring and/or coordinating clinical trials required.

    + Excellent written and verbal communication skills to express complex ideas to study personnel at research and clinical institutions.

    + Demonstrated ability to form strong functional relationships.

    + Excellent, presentation, organizational and interpersonal skills.

    + Ability to interact with all levels of staff to coordinate/execute study activities.

    + Ability to handle several priorities within multiple, complex trials.

    + Ability to reason independently and recommend specific solutions in clinical settings.

    + Ability to work independently, prioritize, and work within a matrix team environment.

    + Ability to mentor other CRAs and co-monitor, as required.

    + Knowledge of electronic data capture including basic data processing functions.

    + Knowledge of current GCP/ICH guidelines applicable to the conduct of clinical research.

    + Able to qualify for a major credit card, rent an automobile

    + For the Technical CTM role, the CRA must have a deep understanding of IQVIA Biotech systems with the ability to learn even more.

    **PHYSICAL REQUIREMENTS:**

    + Very limited physical effort required to perform normal job duties

    + Extensive use of telephone and face-to-face communication requiring accurate perception of speech

    + Extensive use of keyboard requiring repetitive motion of fingers

    + Regular sitting for extended periods of time

    **MINIMUM RECRUITMENT STANDARDS:**

    + BS/BA/BSc (or equivalent) in one of the life sciences or health care background (RPh, RN, etc) and a minimum of four (4) years of monitoring/site management experience is required; or equivalent combination of education, training and experience.

    + Prior Clinical Research Organization (CRO) experience preferred.

    + Prior project team leadership experience preferred.

    + Working knowledge of budget management preferred.

    + Must be able to travel domestically and internationally approximately 65%-85%.

    + Valid driver’s license

    + Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer

    \#CRAIBAJD

    At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com .

    All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.

    IQVIA, Inc. provides reasonable accommodations for applicants with disabilities.  Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.

    IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.

    To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.

    EEO Minorities/Females/Protected Veterans/Disabled


    Employment Type

    Full Time

  • Principal Biostatistician
    IQVIA    Phoenix, AZ 85067
     Posted 7 days    

    Purpose:

    Develop statistical methods sections of protocols and review case report forms (CRFs). Prepare analysis plans and write specifications for analysis files, tables, and figures. Communicate with clients regarding study protocol or statistical analysis issues as they arise. Communicate with study team members regarding study execution as it relates to timelines, data quality, and interpretation of results. Interpret analyses and write statistical sections of study reports. Provide training, guidance and mentorship to lower level and new staff.

    Responsibilities:

    + Coordinate the development of analysis plans, table shells, programming and table specifications, the production of tables, listings and figures, data review and statistical analysis.

    + Perform protocol development, sample size calculation, protocol and CRF review.

    + Advise data management staff on database design, and critical data. May advise on validation checks.

    + Write statistical sections of integrated reports.

    + Provide expert statistical input into and review of statistical deliverables (i.e. analysis plans, table shells, programming and table specifications, data review, tables, listings, figures and statistical sections for integrated reports) and data management deliverables (i.e. database design, validation checks and critical data).

    + Act as statistical team lead for single complex studies or groups of studies.

    + Understand the Scope of Work, budget and quote assumptions, estimate the work completed, manage scope, and provide revenue and resource forecasts for single studies. May manage project budget and resource requirements.

    + Perform the review of RFPs and QIPs, prepare proposal text and attend bid defense meetings.

    + Manage customer relationships.

    + Provide training and guidance to lower level and new staff.

    Required Knowledge, Skills and Abilities:

    + Excellent written and oral communication skills including grammatical/technical writing skills

    + Excellent attention and accuracy with details

    + In-depth knowledge of applicable clinical research regulatory requirements; i.e.,Â

    + Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines Familiarity with moderately complex statistical methods that apply to applicable clinical trials

    + Familiarity with moderately complex statistical methods that apply to applicable clinical trials

    + Strong individual initiative

    + Strong organizing skills

    + Strong working knowledge of SAS computing package

    + Familiarity with other relevant statistical computing packages such as nQuery

    + Strong commitment to quality

    + Ability to effectively manage multiple tasks and projects

    + Ability to lead and co-ordinate small teams

    + Ability to solve moderately complex problems

    + Ability to establish and maintain effective working relationships with coworkers, managers and clients

    + Working knowledge of relevant Data Standards (such as CDISC/ADaM)

    **Location: Home-based anywhere in the US**

    ​

    At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com .

    All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.

    IQVIA, Inc. provides reasonable accommodations for applicants with disabilities.  Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.

    IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.

    To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.

    EEO Minorities/Females/Protected Veterans/Disabled


    Employment Type

    Full Time

  • Fraud Research Analyst- Tucson AZ (WPC)
    CGI Technologies and Solutions, Inc.    Tucson, AZ 85702
     Posted 8 days    

    **Fraud Research Analyst- Tucson AZ (WPC)**

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    **Fraud Research Analyst- Tucson AZ (WPC)**

    **Category:** Administration

    **City:** Tucson, Arizona, US United States

    **Position ID:** J0921-0119

    **Employment Type:** Full Time

    **Position Description:**

    EDUCATION/EXPERIENCE REQUIRED:

    • Bachelor’s Degree (or) 4 years of experience as a Support Associate Level III or IV (or) 4 years of experience in law enforcement, criminal justice, intelligence, or other professional analytic positions, and;

    • Two (2) years of experience in a field that provides the individual with the knowledge, skills and abilities to successfully gather and analyze information from a variety of sources (e.g. criminal justice, psychology, journalism), and;

    • Five (5) years of experience utilizing a variety of office software, specifically: MS Word, MS Power Point, MS Excel, MS SharePoint, MS Access, and MS Outlook, and;

    • Demonstrated experience working independently and as a member of a team that interacts effectively with personnel at all levels.

    QUALIFICATIONS:

    • Excellent written and oral communication skills to draft effective analytical memoranda, reports and presentations, and to disseminate information to a wide audience

    • Analytical skills and attention to detail to successfully analyze and evaluate trends

    • Strong computer and organizational skills and ability to prioritize workflow duties

    • Demonstrated ability to identify areas for improvement in the workflow and quality within the fraud office

    • Must be capable of choosing between varying methods and procedures to process complex cases and provide guidance to other analysts

    • Infrequent travel may be required

    **Your future duties and responsibilities:**

    A Fraud Research Analyst assists the Government Fraud Prevention Managers in providing an advanced level of

    analytical support. Tasks include, but are not limited to, the following:

    • Conduct research on Passport cases by gathering information from a variety of sources, including but not limited to: applications, supporting documents, the internet, telephone calls, Government, commercial and open source databases

    • Perform analyses on reports of investigation, review research conducted and information received from various locations

    • Assist in identifying possible fraudulent activity related to Passport cases

    • Write reports in a clear and concise manner that summarize the information gathered and identified during research

    • Coordinate and network with DOS personnel, other Government agencies, and coworkers to facilitate information sharing on Passport cases that involve fraud or potential criminal activity

    • Perform analyses and develop a written synopsis on suspended cases, to identify trends that may be useful in future research

    • Maintain a working knowledge of a variety of resources that pertain to the eligibility requirements of the various Passport regulations and criminal statutes regulating Passports

    • May be required to perform other duties as assigned to advance the fraud office’s mission of supporting adjudication as it relates to Passport cases

    **Required qualifications to be successful in this role:**

    • (Preferred) Advanced knowledge and understanding of the laws, rules, and regulations governing eligibility for and issuance of a U.S. Passport

    \#CGIFederalJob

    **What you can expect from us:**

    **Build your career with us.**

    It is an extraordinary time to be in business. As digital transformation continues to accelerate, CGI is at the center of this change—supporting our clients’ digital journeys and offering our professionals exciting career opportunities.

    At CGI, our success comes from the talent and commitment of our professionals. As one team, we share the challenges and rewards that come from growing our company, which reinforces our culture of ownership. All of our professionals benefit from the value we collectively create.

    Be part of building one of the largest independent technology and business services firms in the world.

    Learn more about CGI at www.cgi.com .

    No unsolicited agency referrals please.

    CGI is an equal opportunity employer.

    Qualified applicants will receive consideration for employment without regard to their race, ethnicity, ancestry, color, sex, religion, creed, age, national origin, citizenship status, disability, pregnancy, medical condition, military and veteran status, marital status, sexual orientation or perceived sexual orientation, gender, gender identity and gender expression, familial status, political affiliation, genetic information, or any other legally protected status or characteristics.

    CGI provides reasonable accommodations to qualified individuals with disabilities. If you need an accommodation to apply for a job in the U.S., please email the CGI U.S. Employment Compliance mailbox at US_Employment_Compliance@cgi.com . You will need to reference the requisition number of the position in which you are interested. Your message will be routed to the appropriate recruiter who will assist you. **Please note, this email address is only to be used for those individuals who need an accommodation to apply for a job. Emails for any other reason or those that do not include a requisition number will not be returned** .

    We make it easy to translate military experience and skills! Click here to be directed to our site that is dedicated to veterans and transitioning service members.

    All CGI offers of employment in the U.S. are contingent upon the ability to successfully complete a background investigation. Background investigation components can vary dependent upon specific assignment and/or level of US government security clearance held. Qualified applicants with arrest and conviction records are welcome to apply.

    CGI will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with CGI’s legal duty to furnish information.


    Employment Type

    Full Time

  • Senior Clinical Research Associate - Seattle, WA. (REMOTE)
    Merck    Phoenix, AZ 85067
     Posted 12 days    

    **Job Description**

    Subject to applicable law, all prospective hires will be required to demonstrate that they have been fully vaccinated for COVID-19 or intend to be vaccinated for COVID-19 by November 1, 2021, or qualify for a medical or religious accommodation to this vaccination requirement. Hired candidates who are not vaccinated by November 1, 2021, and who have not been approved for a legally-required medical or religious accommodation will be subject to disciplinary action up to and including termination of employment, subject to applicable law.

    Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical standards.

    We care deeply about helping the world be well. We strive to improve health for others in the future by developing new drugs and vaccines that treat and prevent disease. Clinical trials are an essential part of this process. The Senior Clinical Research Associate role is integral to helping the world meet new breakthroughs that affect generations to come, and we're counting on your skills and inventiveness to help make meaningful contributions to global medical advancement.

    + Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.

    + Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.

    + Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.

    + Gains an in-depth understanding of the study protocol and related procedures.

    + Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.

    + Participates & provides inputs on site selection and validation activities.

    + Performs remote and on-site monitoring & oversight activities using various tools to ensure:

    + Data generated at site are complete, accurate and unbiased

    + Subjects' right, safety and well-being are protected

    + Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.

    + Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.

    + Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.

    + Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined Clinical Research Escalation Pathway as appropriate in collaboration with Clinical Research Manager, Partner Line Manager and Regional Clinical Project Manager.

    + Manages and maintains information and documentation in Clinical Trial Management System, electronic Trial Master File and various other systems as appropriate and per timelines.

    + Contributes strongly to Clinical Research Associate team knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required.

    + Supports and/or leads audit/inspection activities as needed.

    + Mentors / buddies junior Clinical Research Associates on process/study requirements and performs co-monitoring visits where appropriate

    **Education and Experience:**

    + B.A./B.S. preferred with strong emphasis in science and/or biology

    + Minimum of 4 years of direct site management (monitoring) experience in a bio/pharma./ Clinical Research Organization.

    **Travel Expectations:**

    + Ability to travel domestically and internationally approximately 65%-75% of working time.

    + Expected travelling 2-3 days/week.

    + Current driver's license preferred.

    **Core Competency Expectations:**

    + Fluent in Local languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.

    + Excellent understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.

    + Excellent understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.

    + Demonstrated ability to mentor/lead

    + Hands on knowledge of Good Documentation Practices

    + Proven Skills in Site Management including independent management of site performance and patient recruitment

    + Demonstrated high level of monitoring skill with independent professional judgment.

    + Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices.

    + Ability to understand and analyze data/metrics and act appropriately

    **Behavioral Competency Expectations:**

    + Effective time management, organizational and interpersonal skills, conflict management, problem solving skills

    + Able to work highly independently across multiple protocols, sites and therapy areas

    + High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment

    + Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships

    + Works with high quality and compliance mindset

    + Demonstrates commitment to Customer focus

    OurResearchDivisionGCTO

    We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And we believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

    **Who we are …**

    We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

    **What we look for …**

    In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization.

    **NOTICE FOR INTERNAL APPLICANTS**

    In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

    If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

    **Residents of Colorado**

    Click here (https://survey.sogosurvey.com/Survey1.aspx?k=SsQYWYYQsQRsPsPsP&lang=0) to request this role’s pay range.

    Current Employees apply HERE (https://wd5.myworkday.com/msd/d/inst/1422$1533/rel-task/3001$14.htmld)

    Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

    **US and Puerto Rico Residents Only:**

    Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.

    For more information about personal rights under Equal Employment Opportunity, visit:

    EEOC Poster (https://www.dol.gov/sites/dolgov/files/ofccp/regs/compliance/posters/pdf/eeopost.pdf)

    EEOC GINA Supplement​

    OFCCP EEO Supplement (https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP\_EEO\_Supplement\_Final\_JRF\_QA\_508c.pdf)

    Pay Transparency Nondiscrimination

    We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

    **Search Firm Representatives Please Read Carefully**

    Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

    **Employee Status:**

    Regular

    **Relocation:**

    No relocation

    **VISA Sponsorship:**

    No

    **Travel Requirements:**

    50%

    **Flexible Work Arrangements:**

    Remote Work

    **Shift:**

    1st - Day

    **Valid Driving License:**

    Yes

    **Hazardous Material(s):**

    **Number of Openings:**

    1

    **Requisition ID:** R138581


    Employment Type

    Full Time

  • Senior Clinical Research Associate-Georgia (REMOTE)
    Merck    Phoenix, AZ 85067
     Posted 12 days    

    **Job Description**

    Subject to applicable law, all prospective hires will be required to demonstrate that they have been fully vaccinated for COVID-19 or intend to be vaccinated for COVID-19 by November 1, 2021, or qualify for a medical or religious accommodation to this vaccination requirement. Hired candidates who are not vaccinated by November 1, 2021, and who have not been approved for a legally-required medical or religious accommodation will be subject to disciplinary action up to and including termination of employment, subject to applicable law.

    Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines, and new indications for existing products. We ensure we conduct high-quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical standards.

    We care deeply about helping the world be well. We strive to improve health for others in the future by developing new drugs and vaccines that treat and prevent disease. Clinical trials are an essential part of this process. The Senior Clinical Research Associate role is integral to helping the world meet new breakthroughs that affect generations to come, and we're counting on your skills and inventiveness to help make meaningful contributions to global medical advancement.

    **Core tasks, including but not limited to, the following:**

    + Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.

    + Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.

    + Performs clinical study site management/monitoring activities in compliance with International Conference on Harmonization Good Clinical Practice, Sponsor Standard Operating Procedures, Local Laws & Regulations, Protocol, Site Monitoring Plan, and associated documents.

    + Gains an in-depth understanding of the study protocol and related procedures.

    + Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.

    + Participates & provides inputs on site selection and validation activities.

    + Performs remote and on-site monitoring & oversight activities using various tools to ensure:

    + Data generated at the site are complete, accurate and unbiased Subjects' right, safety and well-being are protected

    + Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits, and records clear, comprehensive, and accurate visit & non-visit contact reports appropriately in a timely manner.

    + Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance, and study close-out.

    + Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections, and overall site performance.

    + Identifies, assesses, and resolves site performance, quality, or compliance problems, and escalates per defined Clinical Research Associate Escalation Pathway as appropriate in collaboration with Clinical Research Manager, Partner Line Manager, and Clinical Project Manager.

    + Manages and maintains information and documentation in the Clinical Trial Management System, electronic Trial Master File, and various other systems as appropriate and per timelines.

    + Contributes to Clinical Research Associate team knowledge by acting as process Subject Matter Expert, buddy/mentor, and sharing best practices as appropriate/required.

    + Supports and/or leads audit/inspection activities as needed.

    + Mentor/train other Clinical Research Associate team members

    **Education and Experience:**

    + B.A./B.S degree required; strong emphasis in science and/or biology preferred

    + Minimum of 4 years of direct site management (monitoring) experience in a Bio/Pharma. / Clinical Research Organization.

    **Travel Expectations:**

    + Ability to travel domestically and internationally approximately 65%-75% of working time.

    + Expected traveling 2-3 days/week.

    + The current driver's license required.

    **Core Competency Expectations:**

    + Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.

    + Excellent understanding and working knowledge of clinical research, phases of clinical trials, current International Conference on Harmonization Good Clinical Practice (GCP/ICH) & country clinical research law & guidelines.

    + Excellent understanding of Global, Country/Regional Clinical Research Guidelines, and ability to work within these guidelines.

    + Demonstrated ability to mentor/lead

    + Hands-on knowledge of Good Documentation Practices

    + Proven Skills in Site Management including independent management of site performance and patient recruitment

    + Demonstrated high level of monitoring skill with independent professional judgment.

    + Good IT skills (Use of MS office, use of various clinical IT applications on the computer, tablet, and mobile devices) and ability to adapt to new IT applications on various devices.

    + Ability to understand and analyze data/metrics and act appropriately

    **Behavioral Competency Expectations:**

    + Effective time management, organizational and interpersonal skills, conflict management, problem-solving skills

    + Able to work highly independently across multiple protocols, sites and therapy areas

    + High sense of accountability/urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment

    + Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships

    + Works with high quality and compliance mindset

    + Demonstrates commitment to Customer focus

    *** This is a remote-based position**

    OurResearchDivisionGCTO

    We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

    **Who we are …**

    We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

    **What we look for …**

    In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization.

    **NOTICE FOR INTERNAL APPLICANTS**

    In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

    If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

    **Residents of Colorado**

    Click here (https://survey.sogosurvey.com/Survey1.aspx?k=SsQYWYYQsQRsPsPsP&lang=0) to request this role’s pay range.

    Current Employees apply HERE (https://wd5.myworkday.com/msd/d/inst/1422$1533/rel-task/3001$14.htmld)

    Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

    **US and Puerto Rico Residents Only:**

    Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.

    For more information about personal rights under Equal Employment Opportunity, visit:

    EEOC Poster (https://www.dol.gov/sites/dolgov/files/ofccp/regs/compliance/posters/pdf/eeopost.pdf)

    EEOC GINA Supplement​

    OFCCP EEO Supplement (https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP\_EEO\_Supplement\_Final\_JRF\_QA\_508c.pdf)

    Pay Transparency Nondiscrimination

    We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

    **Search Firm Representatives Please Read Carefully**

    Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

    **Employee Status:**

    Regular

    **Relocation:**

    No relocation

    **VISA Sponsorship:**

    No

    **Travel Requirements:**

    50%

    **Flexible Work Arrangements:**

    Remote Work

    **Shift:**

    **Valid Driving License:**

    Yes

    **Hazardous Material(s):**

    **Number of Openings:**

    1

    **Requisition ID:** R138547


    Employment Type

    Full Time

  • Senior Clinical Research Associate-Florida (REMOTE)
    Merck    Phoenix, AZ 85067
     Posted 12 days    

    **Job Description**

    Subject to applicable law, all prospective hires will be required to demonstrate that they have been fully vaccinated for COVID-19 or intend to be vaccinated for COVID-19 by November 1, 2021, or qualify for a medical or religious accommodation to this vaccination requirement. Hired candidates who are not vaccinated by November 1, 2021, and who have not been approved for a legally-required medical or religious accommodation will be subject to disciplinary action up to and including termination of employment, subject to applicable law.

    Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines, and new indications for existing products. We ensure we conduct high-quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical standards.

    We care deeply about helping the world be well. We strive to improve health for others in the future by developing new drugs and vaccines that treat and prevent disease. Clinical trials are an essential part of this process. The Senior Clinical Research Associate role is integral to helping the world meet new breakthroughs that affect generations to come, and we're counting on your skills and inventiveness to help make meaningful contributions to global medical advancement.

    **Core tasks, including but not limited to, the following:**

    + Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.

    + Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.

    + Performs clinical study site management/monitoring activities in compliance with International Conference on Harmonization Good Clinical Practice, Sponsor Standard Operating Procedures, Local Laws & Regulations, Protocol, Site Monitoring Plan, and associated documents.

    + Gains an in-depth understanding of the study protocol and related procedures.

    + Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.

    + Participates & provides inputs on site selection and validation activities.

    + Performs remote and on-site monitoring & oversight activities using various tools to ensure:

    + Data generated at the site are complete, accurate and unbiased Subjects' right, safety and well-being are protected

    + Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits, and records clear, comprehensive, and accurate visit & non-visit contact reports appropriately in a timely manner.

    + Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance, and study close-out.

    + Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections, and overall site performance.

    + Identifies, assesses, and resolves site performance, quality, or compliance problems, and escalates per defined Clinical Research Associate Escalation Pathway as appropriate in collaboration with Clinical Research Manager, Partner Line Manager, and Clinical Project Manager.

    + Manages and maintains information and documentation in the Clinical Trial Management System, electronic Trial Master File, and various other systems as appropriate and per timelines.

    + Contributes to Clinical Research Associate team knowledge by acting as process Subject Matter Expert, buddy/mentor, and sharing best practices as appropriate/required.

    + Supports and/or leads audit/inspection activities as needed.

    + Mentor/train other Clinical Research Associate team members

    **Education and Experience:**

    + B.A./B.S degree required; strong emphasis in science and/or biology preferred

    + Minimum of 4 years of direct site management (monitoring) experience in a Bio/Pharma. / Clinical Research Organization.

    **Travel Expectations:**

    + Ability to travel domestically and internationally approximately 65%-75% of working time.

    + Expected traveling 2-3 days/week.

    + The current driver's license required.

    **Core Competency Expectations:**

    + Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.

    + Excellent understanding and working knowledge of clinical research, phases of clinical trials, current International Conference on Harmonization Good Clinical Practice (GCP/ICH) & country clinical research law & guidelines.

    + Excellent understanding of Global, Country/Regional Clinical Research Guidelines, and ability to work within these guidelines.

    + Demonstrated ability to mentor/lead

    + Hands-on knowledge of Good Documentation Practices

    + Proven Skills in Site Management including independent management of site performance and patient recruitment

    + Demonstrated high level of monitoring skill with independent professional judgment.

    + Good IT skills (Use of MS office, use of various clinical IT applications on the computer, tablet, and mobile devices) and ability to adapt to new IT applications on various devices.

    + Ability to understand and analyze data/metrics and act appropriately

    **Behavioral Competency Expectations:**

    + Effective time management, organizational and interpersonal skills, conflict management, problem-solving skills

    + Able to work highly independently across multiple protocols, sites and therapy areas

    + High sense of accountability/urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment

    + Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships

    + Works with high quality and compliance mindset

    + Demonstrates commitment to Customer focus

    *** This is a remote-based position**

    OurResearchDivisionGCTO

    We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

    **Who we are …**

    We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

    **What we look for …**

    In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization.

    **NOTICE FOR INTERNAL APPLICANTS**

    In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

    If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

    **Residents of Colorado**

    Click here (https://survey.sogosurvey.com/Survey1.aspx?k=SsQYWYYQsQRsPsPsP&lang=0) to request this role’s pay range.

    Current Employees apply HERE (https://wd5.myworkday.com/msd/d/inst/1422$1533/rel-task/3001$14.htmld)

    Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

    **US and Puerto Rico Residents Only:**

    Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.

    For more information about personal rights under Equal Employment Opportunity, visit:

    EEOC Poster (https://www.dol.gov/sites/dolgov/files/ofccp/regs/compliance/posters/pdf/eeopost.pdf)

    EEOC GINA Supplement​

    OFCCP EEO Supplement (https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP\_EEO\_Supplement\_Final\_JRF\_QA\_508c.pdf)

    Pay Transparency Nondiscrimination

    We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

    **Search Firm Representatives Please Read Carefully**

    Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

    **Employee Status:**

    Regular

    **Relocation:**

    No relocation

    **VISA Sponsorship:**

    No

    **Travel Requirements:**

    50%

    **Flexible Work Arrangements:**

    Remote Work

    **Shift:**

    **Valid Driving License:**

    Yes

    **Hazardous Material(s):**

    **Number of Openings:**

    1

    **Requisition ID:** R138545


    Employment Type

    Full Time

  • Senior Clinical Research Associate, Northern/Southern California
    Merck    Phoenix, AZ 85067
     Posted 12 days    

    **Job Description**

    Subject to applicable law, all prospective hires will be required to demonstrate that they have been fully vaccinated for COVID-19 or intend to be vaccinated for COVID-19 by November 1, 2021, or qualify for a medical or religious accommodation to this vaccination requirement. Hired candidates who are not vaccinated by November 1, 2021, and who have not been approved for a legally-required medical or religious accommodation will be subject to disciplinary action up to and including termination of employment, subject to applicable law.

    Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical standards.

    We care deeply about helping the world be well. We strive to improve health for others in the future by developing new drugs and vaccines that treat and prevent disease. Clinical trials are an essential part of this process. The Senior Clinical Research Associate role is integral to helping the world meet new breakthroughs that affect generations to come, and we're counting on your skills and inventiveness to help make meaningful contributions to global medical advancement.

    + Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.

    + Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.

    + Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.

    + Gains an in-depth understanding of the study protocol and related procedures.

    + Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.

    + Participates & provides inputs on site selection and validation activities.

    + Performs remote and on-site monitoring & oversight activities using various tools to ensure:

    + Data generated at site are complete, accurate and unbiased

    + Subjects' right, safety and well-being are protected

    + Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.

    + Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.

    + Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.

    + Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined Clinical Research Escalation Pathway as appropriate in collaboration with Clinical Research Manager, Partner Line Manager and Regional Clinical Project Manager.

    + Manages and maintains information and documentation in Clinical Trial Management System, electronic Trial Master File and various other systems as appropriate and per timelines.

    + Contributes strongly to Clinical Research Associate team knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required.

    + Supports and/or leads audit/inspection activities as needed.

    + Mentors / buddies junior Clinical Research Associates on process/study requirements and performs co-monitoring visits where appropriate

    **Education and Experience:**

    + B.A./B.S. preferred with strong emphasis in science and/or biology

    + Minimum of 4 years of direct site management (monitoring) experience in a bio/pharma./ Clinical Research Organization.

    **Travel Expectations:**

    + Ability to travel domestically and internationally approximately 65%-75% of working time.

    + Expected travelling 2-3 days/week.

    + Current driver's license preferred.

    **Core Competency Expectations:**

    + Fluent in Local languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.

    + Excellent understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.

    + Excellent understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.

    + Demonstrated ability to mentor/lead

    + Hands on knowledge of Good Documentation Practices

    + Proven Skills in Site Management including independent management of site performance and patient recruitment

    + Demonstrated high level of monitoring skill with independent professional judgment.

    + Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices.

    + Ability to understand and analyze data/metrics and act appropriately

    **Behavioral Competency Expectations:**

    + Effective time management, organizational and interpersonal skills, conflict management, problem solving skills

    + Able to work highly independently across multiple protocols, sites and therapy areas

    + High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment

    + Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships

    + Works with high quality and compliance mindset

    + Demonstrates commitment to Customer focus

    We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And we believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

    **Who we are …**

    We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

    **What we look for …**

    In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization.

    **NOTICE FOR INTERNAL APPLICANTS**

    In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

    If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

    **Residents of Colorado**

    Click here (https://survey.sogosurvey.com/Survey1.aspx?k=SsQYWYYQsQRsPsPsP&lang=0) to request this role’s pay range.

    Current Employees apply HERE (https://wd5.myworkday.com/msd/d/inst/1422$1533/rel-task/3001$14.htmld)

    Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

    **US and Puerto Rico Residents Only:**

    Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.

    For more information about personal rights under Equal Employment Opportunity, visit:

    EEOC Poster (https://www.dol.gov/sites/dolgov/files/ofccp/regs/compliance/posters/pdf/eeopost.pdf)

    EEOC GINA Supplement​

    OFCCP EEO Supplement (https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP\_EEO\_Supplement\_Final\_JRF\_QA\_508c.pdf)

    Pay Transparency Nondiscrimination

    We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

    **Search Firm Representatives Please Read Carefully**

    Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

    **Employee Status:**

    Regular

    **Relocation:**

    No relocation

    **VISA Sponsorship:**

    No

    **Travel Requirements:**

    50%

    **Flexible Work Arrangements:**

    Remote Work

    **Shift:**

    1st - Day

    **Valid Driving License:**

    Yes

    **Hazardous Material(s):**

    **Number of Openings:**

    1

    **Requisition ID:** R138107


    Employment Type

    Full Time


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