Senior Director, Clinical Data Management

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. The qualified candidate needs a strong 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.

Key Responsibilities include but are not limited to:

• 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.

Required Qualifications:

• 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.

Small Biotech Focus:

This role is highly "hands-on," requiring the leader to be a "doer" while simultaneously establishing long-term data strategy and infrastructure.

• 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.