Senior Director, Clinical Data Management

Senior Director, Clinical Data Management

Location:South San Francisco, CA – Hybrid, with the ability to be in office 2-3 days per week

Position Summary:

Reporting to the VP, Clinical Operations, the Senior Director, Clinical Data Management will be accountable for the design, implementation, and execution of a data management program(s) to support decision milestones and regulatory requirements. Thequalifiedcandidateneedsastrong understanding of the compliance and technical framework for data management activities and has an innovative drive to help the organization succeed and bring new cures to life.

• Strategic & Operational Leadership:Develop data management plans (DMPs), establish standards (CDISC/SDTM), and oversee EDC system builds, UAT, and database locks.
• CRO/Vendor Oversight:Manage external vendors, ensuring quality deliverables, strict adherence to timelines, and budget compliance.
• Data Integrity & Quality:Ensure compliance with ICH/GCP, regulatory guidelines, and internal SOPs; drive query resolution and SAE reconciliation.
• Cross-functional Collaboration:Partner with Clinical Operations, Biostatistics, and Medical Directors, to support study design and data analysis.
• Function Building:Create and refine Data Management SOPs, processes, and technology infrastructure within a start-up, high-growth setting.

• Experience:10–15+ years of clinical data management experience.
• Education:Bachelor’s or Master’s degree in scientific or technical field.
• Skills:In-depth knowledge of EDC systems (e.g., Medidata RAVE, Veeva, etc.), CDISC standards, and hands-on experience with Regulatory submissions (IND/NDA/MAA).
• Adaptability:Ability to thrive in a rapidly growing environment with changing priorities.
• Communication:Excellent verbal and written skills, able to influence at the executive level.
• Problem-Solving:Proactive, analytical mindset with the ability to resolve complex data issues.
• Hands-on vs. Oversight:While a “Senior Director,” this person will often still be involved in writing DMPs (Data Management Plans) and reviewing data listing in the EDC.
• Building Infrastructure:Expected to create SOPs from scratch or heavily modify existing ones, rather than just adhering to established processes.
• CRO Management:High emphasis on holding external vendors accountable to strict timelines.

• Demonstrated ability to establish strong scientific partnership with internal and external key stakeholders
• Demonstrated leadership and strong communication skills with a documented track record of delivering high quality projects/submissions/trials in a global/matrix environment in pharmaceutical or biotech industry or academia or clinical CRO required
• Vendor Management:Extensive experience in CRO/vendor selection and oversight.
• Regulatory Submissions:Strong track record in supporting NDAs/BLAs or Phase III studies.

Compensation: $260k – $275k, plus Discretionary Bonus.

TRexBio offers a very competitivebenefitsincluding medical, dental, vision, short/long term disability, life insurance as well as 401(k) match, bonus and paid time leave.

TRexBio is proud to be an AA/EEO employer and all qualified candidates will receive consideration without regard to characteristics protected by applicable local, state, or federal law, such as race, color, sex, age, religion, national origin, physical or mental disability, pregnancy, marital status, veteran or military status, genetic information, or sexual orientation.

At TRexBio,you will havethe opportunity to work with amazingly smart humans whostriveto make the world a better place. In addition to our team-centric culture, we believe that your individual creativitywill helpus to beourbest. Our staffhappy hours, organized byour Culture Club,bring us all together in creative and social activities. Our colleagues admire and respect one another. We celebrate our wins, update company news and acknowledge each other’s achievementweekly andmonthlyat all company meetingsthat celebrate our work and our people.