Associate Director / Director, Data Management

The Associate Director / Director of Data Management is responsible for providing strategic leadership and operational oversight for all data management activities across multiple clinical programs. This role ensures the delivery of high-quality, reliable, and regulatory-compliant data to support clinical development and submissions. The incumbent will oversee end-to-end data management activities—from study start-up to close-out—while managing CRO partnerships, ensuring inspection readiness, and driving innovation in data systems and standards. Extensive experience with Medidata products (Rave EDC, RTSM, eCOA, Coder, eTMF, RIM integrations, etc.), data governance, and global regulatory compliance is essential. The individual will play a key role in shaping and implementing SOPs, Work Instructions (WIs), and technology strategies that enhance efficiency and compliance across all studies.

Key Responsibilities
• Strategic Leadership & Oversight
Lead data management strategy across multiple studies and programs, ensuring alignment with corporate and regulatory objectives. Oversee CROs and external partners to ensure consistent quality, compliance, and timely delivery of study data. Act as the primary point of contact for data management oversight, providing direction, decision-making, and escalation management. Ensure study-level data standards, quality metrics, and processes are defined and consistently applied.
• Operational Excellence Across Study Lifecycle
Manage all data management activities from study start-up through database lock and close-out. Oversee development and execution of Data Management Plans (DMPs), edit check specifications, external data transfer agreements, and data validation activities. Ensure data collection systems, workflows, and integrations align with protocol requirements and regulatory expectations. Provide oversight for database design, User Acceptance Testing (UAT), and database release readiness.
•  CRO & Vendor Management
Lead governance and performance management of CROs supporting data management functions. Review and approve study deliverables (CRFs, DMPs, edit checks, transfer specs, listings, and reconciliation plans). Ensure quality oversight, audit readiness, and compliance with contractual obligations. Conduct regular operational reviews and issue resolution meetings with CRO partners.
• Technology & Systems Leadership
Serve as a subject matter expert for Medidata Rave and related platforms (RTSM, eCOA,Coder, eTMF, RIM). Drive implementation and optimization of Data Management Technologies and data integration solutions. Collaborate with IT and Biometrics teams to standardize and enhance system interoperability and data flow. Champion adoption of data standards (CDISC, CDASH) and digital transformation initiatives.
• Compliance, Audits & Regulatory Submissions
Ensure inspection readiness and represent Data Management during regulatory inspections and audits. Oversee development and maintenance of SOPs, WIs, and data governance frameworks ensuring compliance with GCP, ICH, 21 CFR Part 11, GDPR, and related regulations. Contribute to clinical and regulatory submissions by ensuring data integrity, traceability, and completeness.
• Leadership & Mentorship
Provide leadership, guidance, and mentorship to Data Management professionals. Foster a culture of quality, accountability, and continuous improvement. Partner cross-functionally with Clinical Operations, Biostatistics, Programming, and Regulatory teams to ensure data deliverables meet submission requirements.
•  Budget & Resource Management
Develop and manage budgets for data management operations, ensuring cost efficiency and alignment with departmental goals. Forecast resource requirements across ongoing and upcoming studies, ensuring appropriate capacity planning. Provide input into strategic resource allocation and vendor budgeting decisions. Track expenditures against projections and optimize utilization of internal and external resources.

Qualifications
•    Bachelor’s or Master’s degree in Life Sciences, Computer Science, or related discipline.
•    12+ years of progressive experience in clinical data management, with at least 5 years in a leadership or oversight capacity.
•    Extensive experience with Medidata products (Rave EDC, RTSM, Coder, integrations).
•    Proven ability to oversee multiple global studies and CROs concurrently.
•    Deep understanding of clinical data management processes, data standards (CDASH, CDISC), and technology landscape.
•    Experience in authoring and implementing SOPs, WIs, and operational best practices.
•    Demonstrated success in supporting regulatory submissions (NDA, BLA, MAA) and managing inspection readiness.
•    Strong leadership, problem-solving, and decision-making skills with the ability to operate independently.
•    Excellent communication, organizational, and stakeholder management skills.
•    Experience with budget forecasting, cost tracking, and resource planning for multi-study portfolios.