TFS Principal Clinical Data Manager - short term assignment in Durham, North Carolina

The Senior Clinical Data Manager will be working on a short term assignment starting in January. The SCDM will be working directly with a client with the possibility that this project may be extended. Strong RAVE experience is required. Cardiovascular experience is preferred.

ESSENTIAL JOB FUNCTIONS:

Responsible for Clinical Data Management activities for assigned studies:

  • Review Study Protocol

  • Mentor Clinical Data Managers and Senior Clinical Data Managers

  • Develop CRF or review of sponsor-generated CRFs

  • Define and program edit checks

  • Responsible to prepare, finalize and archive all related DM documentation

  • Coordinate validation of database, edit checks and trial and site settings

  • Performs validation of database, edit checks and trial and site settings in studies where not the responsible CDM

  • Perform CRF handling including logging, tracking and sorting

  • Perform Data cleaning and query handling

  • Ensure completion of Quality Control task for the finalization and transfer of the study database and related documents to the sponsor

  • Coordinate the receipt and processing of information for projects as well as electronic data received

  • Provide metrics and status updates to senior management and project leaders and sponsors if required

  • May represent TFS Data Management meetings

  • Responsible to escalate any issues

Requirements

  • Bachelor’s Degree, preferably in life science or nursing, Statistics or Computer Science or equivalent

  • Minimum 8 years relevant data management experience, including 5 years as a Senior Clinical Data Manager

  • Proven data management skills

  • Proven leadership skills

  • Excellent verbal and communication skills

  • Ability to deal effectively with customers

  • Ability and willingness to travel on occasion