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Sr. Clinical Data Manager
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- Job DescriptionThe Sr. Clinical Data Manager (CDM) will be responsible for leading data management activities across clinical development programs.
- The Sr. CDM will be responsible for overseeing outsourced data management activities across vendors (e.g. DMP development, data access plans, eCRF builds, data cleaning, data readiness planning and progress for key deliverables, external data transfers, etc
- The Sr. CDM is responsible for ensuring that deliverables are executed on time, of high quality and in accordance with protocol requirements, ICH GCP guidelines, regulatory requirements, third party vendor specifications, and PMV procedures.
- EDC design, build, UAT (CRFs and Edit Checks)Data collection, reconciliation, processing, coding, reporting, validationReview and approve data management documentation and specifications (data management plans, external data transfer agreements, validation plans etc.)
- Prior experience with Medidata Rave is required, URL administration experience a plus.
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