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Lead Clinical Data Manager

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Lead Clinical Data Manager

Pharmaceuticals

USA

Description

Lead Clinical Data Manager

We are looking for a Lead Clinical Data Manager to join a Biotech company providing hands-on Data Management and oversight of several CRO's in early phase clinical trials. You'll be leading study activities within Clinical data management during study start-up, conduct, close-out and reporting across all phases of clinical trials as well as oversight of vendors/CROs


Role

*Preparation of ongoing data reports and safety reviews; and working collaboratively with the study project team
*Coordinate coding, review and approval of medical history, adverse events and other medications
*Lead teams to review data quality reports. Generate, resolve, and track data queries to ensure the integrity of the clinical data with respect to data guidelines and protocol specifications
*Identify and resolve data management issues, in coordination with cross-functional study team and contract data management service groups, as needed
*Manage access control and role assignments to the clinical database, and coordinate database lock activities
*Participate in internal and external study team meetings, vendor meetings and provide appropriate input as the lead data manager

Experience


*5 years+ as a Lead or Senior Clinical Data Manager within a Pharma or CRO company from either early or late phase clinical trials
*Experience with EDC systems
*Experience in SAS
*Exceptional organisation and communication skills
*Any oversight experience is a plus
*Able to work independently in a fast-moving environment



This is a remote US-based role only.  W2 only, which includes W2 employee benefits including health, dental, vision and more.

 

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Job Details

  • Job Type:

    Contract
  • Rate:

    US $60-70 per hour
  • Job published:

    25 days ago
  • Reference:

    BBBH8670