Senior Manager, Clinical Data Management

Senior Manager, Clinical Data Management

Job Responsibilities:
- Lead Clinical Data Management for multiple clinical trials simultaneously.
- Coordinate day-to-day data management tasks; review data management documents for consistency.
- Review timelines/metrics to ensure databases are delivered on schedule.
- Ensure collected data meets study objectives and company quality standards.
- Participate in cross-functional meetings; provide status, issue, and milestone updates.
- Oversee data management personnel and CRO/vendor activities.
- Lead third-party vendor interactions (e.g., laboratories) for collection, transmittal, and transfer of study data.
- Review data using listings/visualization tools; conduct study-level reviews to identify trends.
- Support development/review/implementation of processes, policies, and SOPs impacting data management.
- Utilize AI tools to optimize workflows and improve execution/decision-making.

Qualifications / Required Skills:
- Bachelor’s degree in Life Science, mathematics, or health-related fields (preferred).
- Minimum 4 years data management experience in pharma/biotech/CRO; extensive hands-on data management.
- Experience with EDC, IVRS, CTMS, eTMF, and other clinical systems; ability to learn new systems.
- Strong GCP knowledge; CDISC/CDASH data structures; ICH guidelines and FDA regulations.
- Strong verbal and written communication; strong analytical/problem-solving.
- Strong knowledge/experience of EDC systems (Veeva preferred).

Preferred:
- Oncology therapeutic area experience.

Benefits (as stated):
- Health coverage (medical, pharmacy, dental, vision); wellbeing programs; 401(k), disability, life insurance, and more.
- Paid time off and holidays (details vary by location/employee type).

Application instruction:
- If role doesn’t perfectly match your resume, you are encouraged to apply anyway.