Clinical Operations Lead

Project overview

Clinical Operations Lead

Responsibilities

• Lead country-level study start-up activities to support the successful delivery of clinical trials across multiple therapeutic areas.
• Oversee clinical trial submissions and approvals, including interactions with MHRA, HRA, Ethics Committees and other regulatory bodies.
• Drive site activation activities, ensuring studies are initiated in line with project timelines and regulatory requirements.
• Collaborate with global study teams, CROs, investigators and site personnel to support efficient study start-up and delivery.
• Manage study amendments throughout the clinical trial life cycle, ensuring compliance with applicable regulations and internal procedures.
• Support site contract and budget activities, including negotiation, execution and ongoing management.
• Maintain accurate study documentation and ensure adherence to ICH-GCP, EU CTR and other relevant regulatory requirements.
• Proactively identify operational risks and implement mitigation strategies to support study milestones and delivery targets.

Requirements

Application Process:

Interested candidates are encouraged to submit their CV outlining their relevant experience and qualifications for this role.

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• Degree in Life Sciences or a related discipline, or equivalent industry experience.
• Proven experience within clinical research, clinical operations or study start-up in a Pharmaceutical, Biotechnology or CRO environment.
• Experience managing UK clinical trial submissions through IRAS, MHRA, HRA and Ethics Committee processes.
• Strong understanding of ICH-GCP, EU CTR and UK clinical trial regulations.
• Experience supporting studies from start-up through to site activation.
• Exposure to site contracts, budgets and vendor/CRO management.
• Experience using clinical systems such as CTIS, Veeva Vault, CPMS or similar platforms.
• Strong stakeholder management, communication and organisational skills.

Project details

Welwyn Garden City

Contract Length: 6 months

Hybrid: 2-3 days in office

£339.27 - £500.00 InsideIR35

Our client, a leading organisation within the pharmaceutical industry, is seeking a highly skilled Clinical Operations Lead to join their clinical research team. This is an exciting opportunity for an experienced professional to lead study start-up activities, support regulatory submissions, and drive the successful activation of clinical trial sites across the UK.

• Start: flexible
• Duration: 6 months
• Remote: hybrid
• Location: Hertfordshire, United Kingdom, GB