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Senior Clinical Data Manager

System One

Job Description

  1. Contract – 12 months.
  2. Hybrid- Must be able to come to Princeton, NJ once per month

Position Title:

Senior Clinical Data Manager, Clinical Data Management

Department: 

Clinical Data Sciences

Reports To:

Senior Director, Clinical Data Sciences

Internal Organizational Relationships:

Daily: Supervisor, Clinical Data Sciences department and colleagues in current study teams/vendors

Weekly: Project Management, Clinical Research, Clinical Operations, and Clinical Pharmacology departments

As needed: Regulatory Affairs department

Once every few months: JT Clinical Data Management (CDM) team

External Relationships:

Daily or weekly (frequency varies depending on the stage of the study): CRO, laboratory, and EDC vendors

Position Summary:

  • Conducting data review, cleaning, and locking database
  • Managing vendors
  • Coordinating EDC database development, preparing data validation specifications, testing, and approving database
  • Developing and revising SOPs and work instructions

Principal Duties and Responsibilities:

Priority

Time

Allocated

  • Assist supervisor in managing departmental projects, timelines, and resources

High

5%

  • Assist supervisor in evaluating the suitability of CROs and other vendor data management services

High

10%

  • Assist with the development of the eCRF and associated tools, prepare data validation specifications and conduct user acceptance testing

High

15%

  • Manage vendors and oversee budgets

High

5%

  • Develop and maintain the data management plan

High

10%

  • Perform ongoing eCRF data reconciliation and cleaning

High

30%

  • Lead the development, integration, review and cleaning of ancillary data

High

15%

  • Develop and revise SOPs and work instructions to support CDM

Medium

5%

  • Contribute to the development and maintenance of eCRF, terminologies and other CDM standards. Participate in the process and quality improvement within CDM to engender an optimal workflow in data collection and processing

Medium

5%

  • Additionally, performs other duties as required and assumes other responsibilities as assigned by the supervisor/manager.

Minimum Experience Requirements:

Minimum of 8 years of experience in CDM in the pharmaceutical industry, including at least one year of experience managing outsourced services

Knowledge, Skills and Abilities:

Technical:

Must be adept at using Word, Excel, PowerPoint, SAS Enterprise Guide (for clinical data review), and Rave EDC system; must have strong biomedical background and clinical knowledge, thorough knowledge of clinical data management from study start up to database lock, and understanding of database structure and CDISC principals

Programming experiences in SAS and data visualization and review tools (such as Spotfire or JReview) are plus

Non-technical:

Must have strong written and oral communication skills, and creative and logical approach to problem solving; must be a team player

Minimum Education Requirements:

Bachelor’s degree in a life science

Working Conditions:

  • Flexible schedule with required core hours
  • Occasional travel is needed

Physical Demands:

  • Most (approximately 95%) work is performed while seated.
  • The work requires participation in face-to-face conversations and meetings as needed, as well as on teleconferences.
  • Occasional oral presentations may be required.
  • The work requires the ability to read written documents, computer screens, and visual presentations.

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, and MOUNTAIN, LTD., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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