Study Start Up Lead

Role: Clinical Study Start Up Lead

Location: Welwyn Garden City (Hybrid, 2-3 days in office per week)

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 role focuses on UK clinical trial start-up, regulatory submissions and site activation. Recent hands-on UK study start-up experience is essential.

Benefits:

• Hybrid working, 2-3 days per week in the office
• 25 days holiday + bank holidays
• On-site, free parking
• 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 or equivalent experience
• Strong knowledge of UK clinical trials, HRA, Ethics and MHRA submissions
• Experience with NHS R&D departments, site contracts and costing templates
• Knowledge of IRAS, CPMS, iCT and ARSAC
• Experience progressing clinical studies through to site activation
• Understanding of ICH-GCP and UK regulatory requirements
• Strong stakeholder management and organisational skills
• Must attend the Welwyn Garden City office at least 2 days per week

The Role:

• Coordinate UK clinical study start-up activities and site activation
• Manage regulatory submissions, approvals and amendments
• Liaise with NHS R&D departments, clinical sites and CROs
• Prepare and manage 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.