Biotech/Pharmaceutical

Senior Clinical Data Manager

Contract

Penfield Search Partners

Contact: Neisha Camacho/Terra Parsons – teamnt@penfieldsearch.com

Job Description: Support multiple studies either in-house or outsourced; provide CRO oversight.  May require overseeing CRO Data managers and performing quality checks for the project deliverables. Supports decision making regarding trial database and CRF designs, timelines, vendor selection, and CRO oversight.

  • Coordinate Database build, Design CRF, author/review Data Management Plan, Data Validation Plan, Edit check specifications and CRF Completion Guidelines per agreed study timelines.
  • 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 or Lab vendors and perform/oversee External data reconciliation and SAE reconciliation.
  • Conduct review/QC 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.
  • Attend meetings and report on study status, metrics, timelines, etc.
  • Other data management department and trial related activities as delegated.

Qualifications:

  • BA/BS in science related field.
  • 4 plus years of experience in clinical data management to include overseeing CRO Data managers and performing quality checks for the project deliverables.
  • Clinical data management background with various 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 working with Real World Data.
  • 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.
  • Familiarity with CDASH, SDTM and medical terminology principles in relation to study design.
  • Good working knowledge of GCP.
  • Hybrid work arrangements will allow work from home combined with your presence on-site at US HQ in Florham Park, NJ.

Tagged as: Senior Clinical Data Manager