Senior Clinical Data Manager

Florham Park, New Jersey
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Type: Direct-Hire

Category: Scientific & Clinical

Compensation Range: 100000.00 - 120000.00 Yearly

Job ID: 154407

Date Posted: 08/06/2020


Job  Title:

Senior Clinical Data Manager

Reports to (Position):

Associate Director, Clinical Data Management

Department:

Biometrics

Location:

NJ

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 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
  • 1-2 years’ 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.

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