Director, Clinical Data Management
$200,980–$243,544 year
RemoteUnited States or San Diego, California, United States
Job Summary
Lead the Clinical Data Management program for a new product, providing end-to-end data management leadership from study start-up through database lock. Develop and drive the data management strategy, including study start-up planning, database build oversight, risk management, and submission readiness. Partner with internal study teams, CROs, and vendors to ensure high-quality, timely, and decision-ready clinical trial data. Oversee CRO relationships and manage key documentation such as Data Management Plans and validation plans. Willing to travel approximately 10% of the time; evening and weekend work may be required.
Required Qualifications
- Bachelor's or Master's degree in Life Sciences, Computer Science, Mathematics, Health Sciences, or a related field
- Minimum of 10 years data management experience in pharmaceutical/biotech/CRO industry
- Demonstrated experience leading study teams, vendors, or direct/indirect reports
- In-depth experience in the Oncology therapeutic area
- Proven ability to manage CRO relationships and oversee data management deliverables
- Experience utilizing AI-enabled tools to improve productivity and work efficiency
- Strong knowledge and experience of EDC systems (Medidata RAVE or Veeva)
- Solid knowledge of GCP, CDISC/CDASH data structures, ICH guidelines and FDA regulations
- Excellent verbal and written communication skills
- Strong analytical and problem-solving abilities
- Willing to travel approximately 10% of the time
- Evening and weekend work may be required
Desired Qualifications
- Radiopharmaceutical experience
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