No 3rd party companies
- Serve as the Data Management Lead for assigned clinical studies from study start-up through database lock
- Lead all data management activities, ensuring database readiness, data integrity, and regulatory compliance.
- Develop, maintain, and execute core Data Management deliverables, including Data Management Plans, CRFs/eCRFs, data validation specifications, and data transfer documentation.
- Oversee database build, edit check development, and User Acceptance Testing (UAT).
- Ensure compliance with GCP, ICH, and applicable regulatory and industry standards.
- Communicate study risks, timelines, and deliverables effectively to cross-functional stakeholders.
- Experience & Qualifications
- 10+ years of progressive clinical data management experience within a small pharma or biotech company
- Demonstrated experience serving as the Lead Clinical Data Manager for clinical studies.
- Proven ability to independently lead end-to-end data management activities from study start-up through database lock with minimal oversight.
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Senior Clinical Data Manager
Redbock - an NES Fircroft company
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