Director/Senior Director, Clinical Data Management

Role Summary

Director/Senior Director, Clinical Data Management responsible for overseeing the design, implementation, and oversight of clinical data systems and processes across multiple clinical development programs. Leads a team to deliver high-quality clinical data in alignment with regulatory requirements, corporate goals, and operational efficiency. Contributes to long-term strategy through data-driven approaches and cross-functional partnerships. May manage projects contracted with service providers as well as internal initiatives.

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.
• Develop and execute 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 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; standardize case report forms across projects.
• 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.
• Support submission readiness, including data integration and final deliverables for regulatory filings.
• Participate in protocol development, 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 (CDISC/CDASH/SDTM) and SOPs.
• Develop and improve clinical data management processes and tools.
• Lead and mentor Clinical Data Managers; coach and foster a high-performing, collaborative environment.
• Evaluate organizational needs, define resource strategies, and manage departmental budgets and headcount planning.

Qualifications

• Bachelor‚Äôs degree in a related scientific discipline; advanced degree preferred.
• 12+ years of progressive experience in clinical data management for Director level, 15+ years for Senior Director level, with leadership responsibility at a sponsor organization.
• Expert knowledge of clinical data management.
• Deep expertise in CDISC/CDASH, SDTM, ICH-GCP, 21 CFR Part 11, and regulatory submission requirements.
• Proven success leading large-scale global studies, vendor oversight, and experience in in-house and outsourced models.
• Hands-on experience with EDC systems (e.g., Medidata Rave, Veeva), clinical systems integration, and risk-based monitoring frameworks.
• Exceptional leadership, analytical, and communication skills with the ability to influence senior stakeholders and executives.

Skills

• Clinical data management leadership
• EDC systems and data capture
• CDISC standards and regulatory submission readiness
• Vendor and CRO management
• Cross-functional collaboration and stakeholder influence
• Data quality strategy and risk-based monitoring

Education

• Bachelor‚Äôs degree in a related scientific discipline; advanced degree preferred

Additional Requirements

• Location: New York, NY (onsite at Syndax corporate office)