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

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