Director, Clinical Data Management

Role Summary

This position is a strategic leader responsible for overseeing the design, implementation, and oversight of clinical data systems and processes across multiple clinical development programs. This role directs a team in delivering high-quality clinical data in alignment with regulatory requirements, corporate goals, and operational efficiency. The Director contributes to the long-term success of the function through data-driven strategies, innovation in systems and processes, and strong cross-functional partnerships. May also be responsible for projects that have been contracted with a service provider, as well as internal projects. Location: New York, NY.

Responsibilities

• Collaborate with senior leadership to define and implement functional and organizational strategy aligned with corporate objectives; participate in long-term planning and policy development.
• Development and execution of data quality strategies, risk-based data review plans, and cross-study harmonization.
• Direct the design, testing, validation, and maintenance of clinical databases and electronic data capture (EDC) systems.
• Ensure consistent application of CDM standards, tools (e.g., CDISC, Medidata Rave), and procedures.
• Oversee issue resolution and data integrity across outsourced vendors and internal teams.
• Provide proactive input into clinical protocol design to ensure data collection strategies align with scientific and regulatory requirements.
• Review and contribute to clinical protocols and statistical analysis plans to ensure alignment with data collection objectives; cross-project consistency and standardization of case report forms.
• Partner with internal stakeholders to align timelines and data delivery requirements.
• Participate in cross-functional study teams; influence protocol design, study setup, and data strategy from study start to submission.
• Actively support submission readiness, including data integration and final deliverables for regulatory filings.
• Participate in protocol development, clinical study reports (CSR), and submission activities.
• Manage relationships with CROs and third-party vendors, ensuring alignment with contractual deliverables and performance expectations.
• Establish standards and oversight processes for EDC setup, CRF development, data validation, discrepancy management, and database lock.
• Drive consistency and scalability through implementation of standards (e.g., CDISC/CDASH/SDTM) and SOPs.
• Development and improvement of clinical data management processes and tools.
• Lead and mentor Clinical Data Managers; provide coaching and foster a high-performing and collaborative environment.
• Participates in the evaluation of organizational needs, defining resource strategies, and managing departmental budgets and headcount planning.

Qualifications

• 12+ years of progressive experience in clinical data management with leadership responsibility at a sponsor organization.
• Expert knowledge of clinical data management.
• Deep expertise of industry standards including CDISC/CDASH, SDTM, ICH-GCP, 21 CFR Part 11, and regulatory submission requirements.
• Proven success leading large-scale global studies, vendor oversight and working in both in-house and outsourced models.
• Expertise knowledge and hands on experience with EDC systems (e.g., Medidata Rave, Veeva), clinical systems integration, and risk-based monitoring frameworks required.
• Exceptional leadership, analytical, and communication skills with the ability to influence senior stakeholders and executives.

Education

• Bachelor’s degree in related scientific discipline; advanced degree preferred.