Clinical Study Start Up Lead

Description

Role: Clinical Study Start Up Lead

Location: Welwyn Garden City, Hertfordshire (Hybrid)

Hours: Full–time

Contract: 6 months, Inside IR35

Pay: .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 holidaysHybrid working, 2–3 days per week in the office6–month contract with competitive daily ratesOpportunity to work within a leading global healthcare organisationExposure to innovative UK clinical trials

The Requirements:

Recent UK clinical study start–up experience is essentialPrevious Study Start Up Specialist, Lead or equivalent experienceStrong knowledge of UK clinical trials, HRA, Ethics and MHRA submissionsExperience working with NHS R&D departments, site contracts and costing templatesKnowledge of IRAS, CPMS, iCT and ARSACExperience progressing UK studies through to site activationStrong understanding of ICH–GCP and UK regulatory requirementsExcellent communication and stakeholder management skillsMust attend the Welwyn Garden City office at least 2 days per weekMust be available within 1 months' notice

The Role:

Coordinate UK clinical study start–up activities through to site activationManage regulatory submissions, approvals and amendmentsLiaise with NHS R&D departments, clinical sites and CROsPrepare and negotiate site contracts, budgets and costing templatesCoordinate Informed Consent Forms and essential documentationTrack study timelines, site readiness and regulatory milestonesResolve 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.

Ad ID: 5419203916