Director, Clinical Data Management

Syndax Pharmaceuticals•New York, NY

4h•Remote

About The Position

Syndax Pharmaceuticals is looking for a Director, Clinical Data Management At Syndax, we are determined to realize a future in which people with cancer live longer and better than ever before. Syndax Pharmaceuticals is a commercial stage biopharmaceutical company developing an innovative pipeline of cancer therapies. The Role: 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.

Requirements

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

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.