Clinical Operations Lead

Role: Clinical Study Start Up Lead
Location: Welwyn Garden City, Hertfordshire (Hybrid)
Hours: Full-time
Contract: 6 months, Inside IR35
Pay: £339.27 - £376.97 per day PAYE basic excluding holiday pay or £450 - £500 per day Umbrella

An excellent opportunity has arisen for an experienced Clinical Study Start Up Lead to join one of our longstanding clients, a leading global healthcare organisation based in Welwyn Garden City.

This is a UK country and site-facing role, focusing on clinical trial start-up, regulatory submissions, site contracts and activation. Recent hands-on UK study start-up experience is essential. Global study management experience alone is not sufficient.

Benefits:

• 25 days holiday + bank holidays
• Hybrid working, 2-3 days per week in the office
• 6-month contract with competitive daily rates
• Opportunity to work within a leading global healthcare organisation
• Exposure to innovative UK clinical trials

The Requirements:

• Recent UK clinical study start-up experience is essential
• Previous Study Start Up Specialist, Lead or equivalent experience
• Strong knowledge of UK clinical trials, HRA, Ethics and MHRA submissions
• Experience working with NHS R&D departments, site contracts and costing templates
• Knowledge of IRAS, CPMS, iCT and ARSAC
• Experience progressing UK studies through to site activation
• Strong understanding of ICH-GCP and UK regulatory requirements
• Excellent communication and stakeholder management skills
• Must attend the Welwyn Garden City office at least 2 days per week
• Must be available within 1 months' notice

The Role:

• Coordinate UK clinical study start-up activities through to site activation
• Manage regulatory submissions, approvals and amendments
• Liaise with NHS R&D departments, clinical sites and CROs
• Prepare and negotiate site contracts, budgets and costing templates
• Coordinate Informed Consent Forms and essential documentation
• Track study timelines, site readiness and regulatory milestones
• Resolve start-up challenges and ensure regulatory compliance

If you're keen to join a leading healthcare organisation where you can use your UK clinical study start-up expertise, then please apply to this Clinical Study Start Up Lead role below or call Chloe McCausland on between 8:30am - 5:00pm.