Senior Clinical Data Manager – Contract
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Job Description
Sr. Clinical Data Manager overseeing global clinical trial data management for BioCryst. Coordinating CROs, vendors, data cleaning, database locks, and regulatory submission support.
Responsibilities:
- Develop and manage all aspects of the global clinical study data management process from study start-up through database lock and regulatory submission support
- Coordinate data management activities with the DM Contract Research Organization, internal and external biostatistics, laboratory vendors, database programming, and trial operations
- Develop, run, review, and maintain laboratory and database data listings
- Identify risks and flag findings during ongoing studies; develop materials and present to CRAs and sites to support consistent, quality data capture
- Lead data cleaning, including issuing queries and providing guidance on query issuance and acceptable closure
- Ensure completeness, correctness, and consistency of routine clinical data and its structure
- Coordinate weekly reconciliation with multiple vendors for timely and quality data entry, laboratory completion and results, and eDiary entry and compliance
- Ensure eCRFs, CCGs, edit checks, SOPs, and DMPs meet study requirements and assist with updates
- Support updates to the Medidata Rave EDC system, associated UAT, and documentation
- Collaborate with internal teams, CROs, and vendors to meet deliverables and timelines for clinical data acquisition, quality review, clinical study reports, and regulatory submission documents
- Collaborate with Statistics and Clinical teams to manage DMC meetings, timelines, data cleaning, EDC and laboratory data transfers, and related activities
- Assist the study manager with tracking database interim review and lock timelines and meeting CDM milestones
- Develop and maintain report metrics for the study team and upper management, including monitoring trends across regions
- Support ad hoc clinical team tasks such as newsletter preparation and CRA training
- Support study-level audit and inspection readiness activities as needed
- Perform other duties as assigned
Requirements:
- Bachelor’s degree with a focus in biological sciences, biometrics, mathematics, etc., or equivalent combination of experience and education
- Minimum of 5 years of data management experience, including at least 2 years at a sponsor company
- Experience and familiarity with Medidata Rave EDC software
- Experience and familiarity with Phase I, II, and III trials, preferably global
- Experience and familiarity with interim analyses and freezing and locking databases
- Excellent communication and time management skills, including collaboration across functional disciplines
- Ability to prioritize study load and associated tasks
- Must be autonomous and independent, take initiative, and manage, own, and lead all aspects of data management while contributing to the overall study team
Benefits:
- Contract role
- Full-time schedule
- Equal employment opportunity protections
- Commitment to compliance with federal, state, and local law
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