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:
Clinical documentation
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.
Requirements
Experience, Skills & Knowledge
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
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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