VP, Clinical Operations and Data Management

Overview

In this role you lead the strategic and operational direction for global clinical trials, ensuring compliant, high-quality studies that meet timelines and budget. You will partner with cross-functional teams to advance the company’s clinical development strategy and support regulatory and commercialization objectives. You address complex study and vendor issues, drive data management strategy, and ensure inspector-ready operations. This is a chance to shape trial execution at scale in a fast-paced biotech environment.

Responsibilities

• Provide strategic and operational leadership for clinical operations and data management across programs from start-up to close-out in compliance with ICH-GCP
• Ensure quality, integrity, and inspection-readiness of clinical and data management activities globally
• Drive cross-functional collaboration to deliver trials on time and within budget
• Lead planning, execution, and reporting of clinical studies with aligned timelines and resources
• Act as 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 for clinical documentation and data management activities
• Coordinate regulatory submissions (e.g., IRB/ethics committees, local authorities)
• Oversee data management strategy including database design, build, maintenance, and locks aligned with biostatistics
• Ensure robust data integrity, record-keeping, and compliant archiving practices
• Oversee clinical sites, academic partners, and vendors to ensure performance, quality, and compliance
• Build and maintain relationships with investigators and key opinion leaders
• Lead, develop, and mentor high-performing teams
• Ensure delivery of high-quality study documentation to meet timelines

Key requirements

• 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, strategic and tactical execution abilities
• 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

• leadership
• stakeholder management
• problem-solving
• clinical operations management
• data management strategy
• ICH-GCP compliance

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