Director/Senior Director, Clinical Data Management
Skills
- Strong knowledge of EDC systems such as Medidata Rave and Oracle InForm.
- Experience with clinical data standards including CDISC, SDTM, and ADaM.
- Hands-on expertise in FDA/EMA regulatory submissions.
- Vendor and CRO management experience.
- Excellent communication, organization, and strategic planning skills.
- Familiarity with data cleaning and analytics tools is a plus.
Responsibilities
- Provide strategic leadership for clinical data management across multiple programs and therapeutic areas.
- Implement continuous improvements in methodology, technology, and study processes.
- Serve as subject matter expert for vendor selection involving CROs and data vendors for EDC, ePRO, and IRT.
- Ensure clinical databases meet regulatory requirements, are tested, locked, and archived on schedule.
- Collaborate with Clinical Operations, Biostatistics, Clinical Science, Translational Medicine, Regulatory, and Pharmacovigilance teams.
- Contribute to protocol and CRF design including data collection strategies.
- Manage and mentor internal data management teams and contribute to departmental growth.
- Represent Data Management in cross-functional meetings and regulatory interactions.
- Stay updated on industry standards and regulatory requirements.
Education
- Bachelor’s degree in Life Sciences, Health Informatics, or related field required.
- Advanced degree preferred.
Benefits
- Competitive salary based on professional background and experience.
- Equal employment opportunity employer practicing nondiscrimination and inclusion.
Average salary estimate
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