Senior Clinical Data Manager
The Judge Group Inc.

Chatham, New Jersey


Location: Chatham, NJ
Description: Our client is currently seeking a Senior Clinical Data Manager

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.

REQUIREMENTS
  • BA/BS in science related field.
  • 4 plus years' experience in clinical data management.
  • Clinical data management background with EDC systems.
  • Strong project management skills.
  • Excellent, verbal, written and interpersonal communication skills.
  • Flexible work arrangements will allow for work from home, but we suggest you live a commutable distance to our offices in Florham Park, NJ to allow for your convenience on days when you do need and/or want to work onsite.

  • PREFERRED SKILLS & EXPERIENCE
  • Prior experience working with studies across all phases or Clinical Development (Phase I - III).
  • Specialized experience with Phase I studies, and/or Post Marketing Surveillance studies, and /or experience 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.

Contact: arawat@judge.com

This job and many more are available through The Judge Group. Find us on the web at www.judge.com



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