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Sr. Clinical Data Manager

Sr. Clinical Data Manager

Job Title: Sr. Clinical Data Manager
Contract Type: Permanent
Location: Virginia
Industry:
Salary: Negotiable
Reference: Am10007
Contact Name: Amy Ma
Contact Email: a.ma@sciproglobal.com
Job Published: February 10, 2017 16:34

Job Description

Position responsibilities include but are not limited to:

  • Responsible for the clinical data management (CDM) activities from protocol concept review through completion of the clinical study report for the entire life cycle of multiple clinical trials (Phase I - Phase III).

  • Accountable for ensuring data quality and timeliness of study related CDM deliverables.

  • Coordinates study start-up activities.

  • Conducts peer review, develops and implements QC plan for CDM deliverables from internal and functional service providers (CROs).

  • Data review and cleaning to ensure data quality. Executes DRGs and manages query flow.

  • Coordinates interim and final database audits according to QC plan.

  • Interim and final Data transfers from CRO.

  • Coordinates Medical coding and SAE reconciliation efforts.

  • Generates and reviews CDM metrics for study management team (SMT); identifies and communicates data trends to SMT; reconciles safety and other external data with CRF data; reviews any study-specific quality objectives and ensures these are reflected in the study Data Management Plans.

  • Develops/maintains CDM timelines for assigned studies with input from study team and all relevant functions.

The successful candidate will have 10-12 years of pharmaceutical experience, with 8 or more years of experience within clinical data management.

For an opportunity to discuss this unique opportunity in more detail please contact me at A.Ma@sciproglobal.com or 646 810 3847

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