Clinical Data Management Lead
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Job Summary
Seeking a Clinical Data Management Lead on a contract basis, this remote position will manage clinical data management activities across development programs, ensuring data quality and regulatory compliance while collaborating with internal teams and external vendors.
Key Responsibilities
- Execute daily clinical data management tasks including database design, data review, and database lock for assigned studies
- Lead CRO data management activities, ensuring deliverables meet quality standards and timelines while identifying and resolving risks
- Ensure compliance with FDA, ICH-GCP, and other regulatory requirements throughout all data management activities
Required Qualifications
- Bachelor's degree in life sciences, health informatics, computer science, or a related field
- Minimum 8 years of clinical data management experience in the pharmaceutical/biotech industry
- Strong expertise in managing data for Phase I-III clinical trials across multiple therapeutic areas
- Solid knowledge of GCP, 21 CFR Part 11, and global regulatory requirements
- Experience working with or overseeing CROs performing data management activities
Complete Job Description
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