Clinical Study Start Up 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 (phone number removed) between 8:30am - 5:00pm