Director, Clinical Data Management

Cardio‑Metabolic Biotech

About the Role

We are a rapidly growing cardio‑metabolic biotechnology company advancing first‑in‑class therapies designed to address the most pressing unmet needs in cardiovascular and metabolic disease. As our Director of Clinical Data Management, you will take a strategic leadership role in shaping how clinical data is collected, curated, governed, and transformed into decision‑ready insights across our global clinical portfolio.

This role is central to ensuring our clinical development programs-from early translational studies through late‑stage trials-are powered by high‑quality, reliable, and compliant data. You will collaborate closely with cross‑functional leaders to define data strategy, streamline execution, and ensure our studies progress with operational excellence.

Key Responsibilities

Strategic Leadership & Data Governance

• Develop and own the overarching data management strategy for cardio‑metabolic clinical programs, ensuring that all data flows meet scientific, regulatory, and operational needs.
• Serve as the senior data lead within clinical teams, partnering with Clinical Operations, Biostatistics, Medical Affairs, and Regulatory to drive trial success.
• Establish frameworks that ensure clinical data integrity, traceability, and readiness for submission.

Vendor & Partnership Oversight

• Function as the primary point of contact for CROs, EDC providers, specialty labs, and external data vendors supporting cardiovascular or metabolic endpoints.
• Review, negotiate, and assess CRO and vendor proposals, ensuring alignment with operational and scientific requirements.
• Lead vendor governance activities, including oversight of timelines, deliverables, reconciliation processes, and quality metrics.

Operational Execution

• Oversee end‑to‑end data management activities such as:
  • EDC system build, UAT, maintenance, and database lock/unlock cycles
  • SAE/AE reconciliation
  • External lab and device (e.g., ECG, continuous glucose monitoring) data integration
  • Protocol deviation tracking
  • Coding review across MedDRA/WHODrug
  • Query review, resolution, and improved data‑cleaning workflows
• Ensure all studies follow Data Management Plans (DMPs) and adhere to rigorous quality and compliance standards.

Cross‑Functional Collaboration

• Review clinical protocols, statistical analysis plans, and study documents to ensure robust data capture for cardio‑metabolic endpoints and biomarkers.
• Translate complex clinical or scientific objectives into practical data‑collection strategies and CRF designs.
• Partner with Biostatistics on dataset specifications, data transfer plans, validation checks, and downstream analysis needs.

Team Leadership

• Build, mentor, and guide a high‑performing data management team.
• Foster a culture of accountability, innovation, scientific curiosity, and operational excellence.

Qualifications

• MS or BS/BA degree in a scientific, technical, or healthcare discipline.
• 15+ years of progressive clinical data management experience within the pharmaceutical or biotech industry, including leadership roles.
• Proven experience supporting early and late‑phase clinical trials, preferably in chronic disease, cardiovascular, metabolic, or related therapeutic areas.
• Strong knowledge of clinical database systems, EDC platforms, coding dictionaries, data standards, and regulatory expectations (ICH, GCP, FDA).
• Excellent understanding of clinical data flows, external vendor integrations, and data audit practices.
• Exceptional leadership, cross‑functional collaboration, and communication skills.
• Demonstrated ability to thrive in a dynamic, fast‑moving biotech environment while managing multiple priorities.
• Industry experience required.