Full job descriptionRole: 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.