Clinical Data Manager

Reference: HAR-16-025

Client

Not applicable. This position is open for internal work at HarmonyCR.

Main purpose

The Clinical Data Manager (CDM) is responsible for the project management, complete oversight and timely delivery of clinical trial data and documentation according to agreed upon quality expectations and timelines.

Tasks

  • Liaise with all involved partners to establish, align and confirm data management expectations.
  • Gather content and integration requirements for eCRF and other data collection tools.
  • Establish conventions and quality expectations for clinical data.
  • Establish expectations for dataset content and structure.
  • Set timelines and follow-up regularly to ensure delivery of all data management milestones.
  • Participate in UAT and performs trial data QC.
  • Prepare or review clinical data management documents.
  • Plan and track content, format, quality and timing of data management deliverables, including but not limited to (e)CRF, data management plan, data validation plan, final datasets, database lock.
  • Coordinate medical coding activities (e.g., MedDRA, WHOdrug).
  • Present and train project team and site staff (during investigator meeting, site initiation visit)

Requirements

  • Bachelor or Master degree or equivalent work experience. Life sciences background is preferred.
  • At least 3 years of experience in data management functions.
  • Knowledge of applicable international guidelines regarding data management of clinical trials.
  • Knowledge and understanding of current industry standards (i.e., CDISC, SDTM, CDASH, …).
  • Knowledge of technology platforms for data exchange
  • Knowledge of eDC systems.
  • Good command of spoken and written Dutch and English.
  • Ability to manage multiple priorities and projects within the area of responsibility.

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