Senior Clinical Project Manager

The Senior Clinical Project Manager will provide end-to-end operational leadership for my client's clinical trial(s), ensuring delivery to time, cost, and quality standards. This individual will establish fit-for-purpose clinical operations frameworks, oversee CRO-led execution, and build a high-performing internal team while maintaining inspection readiness at all times.

This role is ideal for someone who combines operational discipline with pragmatic decision-making, and who is comfortable operating in a lean, fast-growing environment.

Key Responsibilities

Clinical Operations Leadership

• Provide operational leadership for Phase 2/3 interventional clinical studies, with particular relevance to dermatology and/or wound care.
• Act as the primary operational owner for CRO-managed studies, ensuring high-quality execution.
• Ensure trials are delivered in line with agreed timelines, budgets, and quality expectations.

Vendor Oversight & Governance

• Lead CRO and vendor selection, onboarding, and ongoing management.
• Establish and run effective governance structures, including KPIs, oversight meetings, and escalation pathways.

Regulatory-Ready Delivery

• Ensure clinical trials are conducted to support UK/EU regulatory submissions.
• Maintain continuous inspection readiness, anticipating regulatory expectations and risks.
• Partner closely with Regulatory Affairs to support submissions and responses.

Quality & Compliance

• Ensure compliance with ICH GCP, UK/EU clinical trial regulations, and internal quality systems.
• Oversee Trial Master File (TMF) completeness, accuracy, and audit readiness.
• Proactively manage deviations, CAPAs, and inspection-related activities.

Operational Infrastructure & Systems

• Design, implement, and maintain:
• Clinical oversight plans
• Risk management plans
• Monitoring strategies
• Vendor governance frameworks
• Study start-up processes and timelines

Team Leadership & Development

• Line manage and mentor clinical operations staff (e.g. Clinical Study Managers, Clinical Trial Assistants).

Cross-Functional Collaboration

• Work closely with:
• Regulatory Affairs
• Medical / Clinical Development
• Quality Assurance
• CMC / Manufacturing (particularly relevant to dermatology and wound care products)
• Translate complex operational challenges into clear, actionable recommendations for senior leadership.

Essential Experience & Qualifications

Clinical Operations Experience

• Proven experience leading clinical operations for Phase 2 or Phase 3 interventional studies.
• Strong background overseeing CRO-run trials.

Regulatory & Compliance Expertise

• Demonstrated experience delivering studies to support UK/EU regulatory submissions.
• Deep working knowledge of ICH GCP, UK clinical trial regulations, and inspection readiness.

Operational Excellence

• Experience implementing or refining clinical operations frameworks, including oversight, risk management, and monitoring strategies.

Leadership Experience

• Direct line management experience of clinical operations staff (CSMs, CTAs, or equivalent).

For a confidential conversation please apply today.