Job Summary
This position entails the supervision of clinical data management for various oncology programs, focusing on the management of CRO and vendor deliverables, external data processes, database creation and validation, data assessment, and preparation for database locking. The role emphasizes the establishment and enhancement of compliant data management practices, in collaboration with cross-functional teams, to guarantee that trial data is of high quality, timely, and ready for inspection.
Responsibilities
- Oversee clinical data management activities across multiple oncology programs.
- Manage deliverables from CROs and vendors, ensuring adherence to timelines and quality standards.
- Coordinate external data workflows and oversee database development and testing.
- Conduct thorough data reviews and prepare for database lock readiness.
- Establish and refine compliant data management processes within cross-functional teams.
Qualifications
- Bachelor’s or advanced degree in life sciences, healthcare, or a related discipline, or equivalent educational experience.
- A minimum of five years of progressive experience in clinical data management within the pharmaceutical or biotechnology sectors.
- Practical experience in CRO and vendor oversight, as well as knowledge of EDC and database systems.
- Familiarity with CDISC/SDTM standards and clinical data verification.
- Strong organizational and communication abilities; experience in oncology and advanced-phase trials is advantageous.
