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 Randamp;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 Randamp;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.