The Vice President of Clinical Operations and Data Management (CODM) provides strategic leadership for the planning, execution, and oversight of global clinical trials. This role is accountable for delivering high-quality, compliant, patient-focused studies on time and within budget, while advancing the organization's clinical development strategy and supporting global regulatory and commercialization objectives.
Key Elements and Responsibilities
- Provide strategic and operational leadership for clinical operations and data management across programs, from study start-up through close-out, in compliance with ICH-GCP.
- Ensure the quality, integrity, and inspection-readiness of all clinical and data management activities globally.
- Drive cross-functional collaboration to deliver clinical trials on time and within budget.
- Lead planning, execution, and reporting of clinical studies, ensuring alignment on timelines, deliverables, and resources.
- Act as the primary escalation point for critical study and vendor issues.
- Oversee study budgets, timelines, resources, and financial tracking.
- Partner with Clinical Science, Biostatistics, and external vendors to ensure seamless delivery of: o Clinical documentation o Data management activities
- Ensure effective coordination of regulatory submissions (e.g., IRB/ethics committees, local authorities).
- Oversee data management strategy and execution, including database design, build, maintenance, and database lock activities, in alignment with biostatistics.
- Ensure robust data integrity, accurate record-keeping, and compliant archiving practices.
- Provide oversight of clinical sites, academic partners, and vendors (e.g., CROs, labs) to ensure performance, quality, and compliance.
- Build and maintain strong relationships with investigators and key opinion leaders.
- Lead, develop, and mentor high-performing teams.
- Ensure delivery of high-quality study documentation to meet program timelines.
Qualifications
- Extensive experience in clinical operations leadership within biotech/pharma.
- Strong clinical project and program management expertise.
- Proven track record managing CROs and external vendors.
- Solid understanding of global regulatory requirements (ICH-GCP).
- Experience managing budgets and resource planning.
- Strong problem-solving skills with the ability to operate strategically and tactically.
- Excellent leadership, communication, and stakeholder management skills.
- Ability to thrive in a fast-paced, evolving biotech environment.
- Experience in rare/orphan diseases and/or academic collaborations is a plus.
Education & Experience
- Bachelor's degree in Life Sciences required.
- Advanced degree (MS, PhD, or equivalent) preferred.
- Substantial experience leading Clinical Operations and Data Management teams.
- Experience in rare disease; gene and cell therapy experience is a plus.
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Vice President of Clinical Operations and Data Management (CODM) in City of Westminster employer: Orchard Therapeutics
Orchard Therapeutics is an exceptional employer located in Hammersmith, UK, offering a dynamic work environment that prioritises health, safety, and compliance. With a strong commitment to employee growth, the company provides comprehensive training programmes and fosters a culture of inclusivity and diversity, ensuring that every team member feels valued and empowered. Joining Orchard means being part of a pioneering organisation at the forefront of gene therapy, where your contributions directly impact the lives of patients with rare disorders.
