Sr. Director Clinical Data Management
San Diego, CA - Hybrid
198,000-286,000
A leading biotech company, based in San Diego, is advancing its first two programs into the clinic this year. Their advanced drug discovery platform uses cutting-edge technology to design highly targeted cancer therapies. This innovative approach aims to create precise treatments with improved efficacy and reduced side effects, driving their mission to revolutionize cancer care .Backed by over $200 million in funding from top-tier investors, the company is well-positioned for rapid growth. The leadership team includes an award-winning CEO recognized for entrepreneurial excellence and a CMO with a distinguished track record in precision medicine and immunotherapy. Joining this company means contributing to innovative cancer treatments within a dynamic, well-funded environment alongside passionate experts committed to transforming oncology.
The Senior Director of Clinical Data Management Responsibilities will include:
- Leading clinical data management oversight of clinical trials, including project management, CRO management, coordination of internal reviews, and approval of routine data management deliverables.
- Setting up data management vendors as required, including the review of RFPs, evaluating, and negotiating data management budgets and contracts.
- Leading the development and review of all Clinical Data Management-related documents, including Data Management Plans, CRF design and CRF Completion Guidelines, edit check specifications, data transfer plans, etc.
- Liaising with study management CRO and internal cross-functional teams to ensure adequate site training, timely initiation, and overall data integrity.
- Providing direction and guidance to team members, including consultants and vendors, as well as other cross-functional groups to achieve study goals and milestones.
- Overseeing database design and post-production updates, ensuring that CROs, vendors, and internal staff meet the highest quality standards per the latest industry standards and regulatory requirements.
- Being responsible for sponsor user acceptance testing, including documenting findings and resolving issues with CRO.
- Overseeing data management activities, including reconciliation between external data and EDC data, data flow metrics, database migration, medical coding, and driving data snapshot/closeout activities.
- Proactively identifying risks and executing risk mitigation strategies; maintaining timely communication with both upper management and cross-functional teams.
- Supervising CRO/Vendor activities to ensure GCP compliance, quality expectations are met, and timelines are adhered to.
- Contributing to program deliverable timeline creation and project re-forecasting.
- Supporting data management activities for regulatory submissions.
- Leading the development of CDM-related Standard Operating Procedures (SOPs) and Work Instructions.
- Performing additional duties as assigned.
Qualifications
- Bachelor's degree mandatory, with a minimum of 6years hands-on data management experience in the CRO, biotech, or pharmaceutical sector.
- Oncology experience required.
- Strong vendor management skills
