Study Start Up Lead

Clearline Recruitment Ltd; Welwyn Garden City; Hybride; GBP 88 000 - 98 000; Plein temps

Avantages offerts par ce poste

Hybrid working

25 days holiday + bank holidays

On-site free parking

6-month contract with competitive pay

Exposure to UK clinical trials

Résumé du poste

Clearline Recruitment Ltd. in Welwyn Garden City is partnering with a leading global healthcare organisation to appoint an experienced Clinical Study Start Up Lead. The role focuses on UK study start-up, regulatory submissions and site activation, with hands-on responsibility for end-to-end regulatory milestones.

The position is hybrid, based in Welwyn Garden City with 2–3 days in the office. It is a 6-month contract Inside IR35, offering competitive rates and the chance to contribute to

Qualifications

• Recent UK clinical study start-up experience is essential.
• Experience with NHS R&D departments, site contracts and costing templates.
• Strong knowledge of UK regulatory submissions (HRA, MHRA) and ethics approvals.
• Proven stakeholder management and organisational skills.
• Must attend the Welwyn Garden City office at least 2 days per week.

Responsabilités

• 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.

Connaissances

Clinical start-up

Regulatory submissions

Stakeholder mgmt

NHS R&D knowledge

Outils

IRAS

CPMS

iCT

ARSAC

Description du poste

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