Sr. Clinical Data Manager (contract)

JOB SUMMARY: The Sr. Clinical Data Manager is responsible for developing and managing all aspects of the global clinical study data management process from start-up to database lock and regulatory submission support.

This position coordinates activities with the DM Contract Research Organization (CRO), internal and external biostats, laboratory vendors, database programming and trial operations to define and implement data management requirements.

ESSENTIAL DUTIES & RESPONSIBILITIES: Ability to develop and own processes related to data compilation, tracking, maintenance, cleaning, and finalization including the ability to develop, run, review, and maintain data listings for laboratory and database data.

Proactively identifies risks and flags findings during ongoing study to clinical management and may develop materials and present to CRAs, sites to ensure consistent, quality data capture.

Facilitates and leads all data cleaning including issuing queries along with guidance on issuance and acceptable closure of queries on an ongoing basis. Demonstrates a strong understanding of the assigned study protocol(s), critical tasks, and associated milestones.

Ensures completeness, correctness and consistency of routine clinical data and its structure. Work closely with DM CRO to ensure weekly reconciliation with multiple vendors for timely and quality data entry, lab completion and resulting, and eDiary data entry and compliance.

Work closely with DM CRO to ensure all eCRFs, CCGs, Edit Checks, SOPs and DMPs meet study requirements and assist with updates as required. Assistance with any required updates to the Medidata Rave EDC system and associated UAT, and updated documentation.

Works collaboratively with both internal team members and associated CROs / vendors to meet project deliverables and timelines for clinical data acquisition, quality review, clinical study reports, documents required for regulatory submission and assistance as needed. Close collaboration with Stats