ABOUT THE ROLEReporting to the Vice President, Biostatistics, the SD/ED of Clinical Data Management will lead the Clinical Data Management function and be responsible for ensuring high-quality, timely, and regulatory-compliant clinical data across the company's development programs. This individual will provide strategic and operational leadership for clinical data management activities, with a particular focus on effective oversight of CROs and other external vendors.
The Senior Director, Clinical Data Management will establish fit-for-purpose data management processes, standards, and governance as the company advances its clinical programs through late-stage development and regulatory submission. The role will work closely with Clinical Operations, Biostatistics, Statistical Programming, Medical, Pharmacovigilance, Regulatory Affairs, and external partners to ensure clinical databases are designed and managed to support efficient study conduct, analysis, and regulatory submissions.
This is a hands-on leadership role requiring both strategic oversight and the ability to directly lead study-level data management activities when needed, including serving as the study Data Management Lead based on program priorities and resource needs.
This is a full-time, South San Francisco-based position with the expectation of working on-site at least three days per week.
KEY RESPONSIBILITIES- Lead the Clinical Data Management function and provide strategic and operational direction across clinical development programs.
- Provide hands-on study-level data management support and serve as the Data Management Lead for individual studies when needed.
- Oversee clinical data management activities throughout the study lifecycle, from study start-up through database lock and archival.
- Provide sponsor oversight of CROs and external data management vendors, ensuring quality, timelines, and deliverables meet company expectations.
- Oversee the development and maintenance of eCRFs, clinical databases, Data Management Plans, edit checks, and data review processes.
- Lead data cleaning, query management, medical coding, reconciliation, and database lock activities.
- Oversee the integration and reconciliation of external data, including central laboratory, PK/PD, IRT, eCOA, imaging, and safety data.
- Establish and maintain data management standards, SOPs, processes, templates, and best practices across studies and programs.
- Partner with Clinical Operations, Medical, Biostatistics, Statistical Programming, Pharmacovigilance, and other functions to ensure timely and high-quality clinical data.
- Ensure clinical data collection and management processes support CDISC standards, downstream statistical analyses, and regulatory submission requirements.
- Establish data quality metrics and proactively identify and resolve data quality, operational, and timeline risks.
- Ensure clinical data management activities and documentation are compliant with GCP, applicable regulatory requirements, and inspection-ready.
- Support regulatory submissions, regulatory authority responses, audits, and inspections related to clinical data.
- Evaluate and implement fit-for-purpose systems, tools, automation, and data review approaches to improve data quality and operational efficiency.
- Build and develop the Clinical Data Management function, including resource planning, vendor strategy, and management and mentoring of internal staff and consultants
QUALIFICATIONS- Bachelor's degree in life sciences, health sciences, computer science, or a related field; advanced degree preferred.
- 15 + years of progressive clinical data management experience in the biotechnology, pharmaceutical, and/or CRO industry.
- Significant experience leading data management activities for Phase 2 and Phase 3 clinical trials, preferably in a sponsor environment.
- Demonstrated experience serving as a study Data Management Lead, with hands-on responsibility from study start-up through database lock.
- Experience leading or providing oversight of CROs and external data management vendors, including management of quality, timelines, and deliverables.
- Strong experience with EDC systems, preferably Medidata Rave, and with eCRF design, database development, edit checks, data cleaning, external data reconciliation, and database lock.
- Strong knowledge of GCP, regulatory requirements, and clinical data management standards and best practices.
- Working knowledge of CDISC/SDTM and understanding of how clinical data collection and database design affect downstream statistical analyses and regulatory submissions.
- Experience with MedDRA and WHODrug coding and management of external data such as central laboratory, PK/PD, eCOA, IRT, and safety data.
- Experience supporting late-stage development, regulatory submissions, audits, and regulatory inspections is highly desirable.
- Demonstrated ability to develop and implement data management SOPs, standards, processes, and governance.
- Strong leadership, vendor-management, communication, and cross-functional collaboration skills, with the ability to operate both strategically and hands-on in a growing biotech environment.
PAY RANGEThe salary range for this role is $250,000 - $300,000. Compensation and title will be competitive and commensurate with the candidate's experience, qualifications, and the responsibilities of the position.
