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Associate Director, Clinical Data Management
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- Reporting to the Senior Director, Clinical Operations, the incumbent will provide leadership and guidance for all phases of clinical studies from the EDC study design through to study closeout and be responsible for the oversight and management of clinical data management activities outsourced to CROs. KEY ROLES AND RESPONSIBILITIESResponsible for the oversight of Clinical Data Management activities outsourced to CROs to ensure adherence to the scope of work and service agreements.
- Collaborate with clinical study teams and vendors to ensure project deliverables are met, including data acquisition, quality data review, and reporting in compliance with GCP, SOPs, and regulatory requirements.
- Contribute to the development, review, and implementation of Clinical Data Management processes, policies, and SOPs. Proficiency in, and ability to learn new, clinical systems including EDC, IVRS, CTMS, eTMF and other clinical project management tools required.
- Experience in Industry Standards (e.g., CDISC) in the collection (CDASH), tabulation (SDTM), or analysis (ADaM) models.
- Experience with Medidata Rave (EDC) and Metadata Repository (MDR) is preferred.
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