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System One Senior Clinical Data Manager in Florham Park, New Jersey

Job Title:

Senior Clinical Data Manager

Reports to (Position):

Director, Clinical Data Management

Department:

Data Management, Biometrics

Location:

NJ (hybrid role)

Purpose and Scope of Position

The Senior Clinical Data Manager works closely with the Biostatistics, Programming, Clinical and Medical Research groups in all aspects of overseeing the CRO DM OR performing all in-house data management including setting up, managing and completing trials within timelines with the primary goal of ensuring data integrity.

This position entails partnering with cross functional groups and decision-making responsibilities regarding trial designs, Data Management deliverables and timelines.

Responsibilities

  • Support or Manage multiple studies in-house and provide CRO oversight (May operate as the Trial Data Lead (TDL) depending on study needs)

  • Coordinate Database build, Design CRF, author Data Management Plan, Data Validation Plan, Edit check specifications and CRF Completion Guidelines for an inhouse study.

  • Review and provide guidance/inputs to CRO for all outsourced Data Management activities including but not limited to CRF design, Data Management Plan, Data Validation Plan, Edit check specifications and CRF Completion Guidelines.

  • Participate in User Acceptance Testing activities as needed.

  • Liaise with Safety team and perform/oversee SAE reconciliation.

  • Conduct review of clinical trial data; write/resolve queries and track the status of data cleanliness and perform all tasks required for database lock.

  • Respond and provide trial related support to cross functional groups such as Biostatistics, Clinical Research, etc.

  • Assist in developing SOP and Working Practices

  • Attend meetings and report on study status, metrics, timelines, etc

  • Other data management department and trial related activities as delegated

  • Entails decision making responsibilities regarding trial database and CRF designs, timelines, vendor selection, and CRO oversight

    Minimum Job Requirements

  • BA/BS in science related field

  • 2 years’ solid Data Management experience (with Lead /Oversight experience) in clinical data management

  • Clinical data management background with EDC systems

  • Strong project management skills

  • Excellent, verbal, written and interpersonal communication skills

    Preferred Skills and Experience

  • Prior experience of working with studies across all phases or Clinical Development (Phase I – III). Specialized experience with Phase I studies or Post Marketing Surveillance studies or experience of working with Real World Data is a plus.

  • Familiarity with tools such as J review, SAS and Excel and proficiency with Electronic Data Capture systems preferably with Medidata Rave. Knowledge of e-source/ePRO/eCOA data is a plus.

  • Familiarity with CDASH, SDTM and medical terminology principles in relation to study design

  • Experience in RBM, or Centralized Monitoring is preferred.

  • Good working knowledge of GCP.

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services 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 full-time 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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