Clinical Study Start Up Lead

Role: Clinical Study Start Up Lead

Location: Welwyn - Hybrid (2/3 days in office)

Hours: Full-time

Pay: £339.27 - £376.97 per day PAYE basic or £450 - £500 per day UMB

Contract: 6-month contract, Inside IR35

An excellent opportunity has arisen for a Clinical Study Start Up Lead to join one of our longstanding clients, a global healthcare organisation, supporting the efficient and compliant start-up of UK clinical trials.

This is a country and site-facing position requiring strong, recent UK study start-up experience. You will lead start-up strategy and execution, regulatory submissions, site activation, contracts and budgets while working closely with clinical sites, internal teams and external partners.

Benefits:

6-month contract opportunity

£450 - £500 per day UMB or £339.27 - £376.97 per day PAYE basic

Hybrid working

Free on-site parking

Opportunity to support complex UK clinical studies

Work across country, site and global study teams

Exposure across multiple therapeutic areas

The Requirements:

Strong and recent UK clinical trial start-up experience

Demonstrable experience taking studies through site set-up to site activation

Strong knowledge of UK clinical trial submissions, including HRA, Ethics and MHRA

Experience with UK-specific clinical start-up systems including IRAS, CPMS, iCT and ARSAC

Experience with clinical site contracts, costing templates, budgets and negotiations

Strong understanding of ICH-GCP, EU CTR and UK regulatory requirements

Experience managing site relationships and working cross-functionally

Experience managing vendor and CRO relationships

Knowledge of study amendments and regulatory coordination throughout the study lifecycle

Degree in Life Sciences or equivalent; postgraduate qualification desirable

Experience with clinical systems such as Veeva Vault, CTIS or RIM would be advantageous

Excellent communication, organisation and problem-solving skills

Ability to lead within complex, matrixed and global teams

The Role:

Lead the UK country strategy for clinical study start-up

Drive study start-up activities from initial planning through to site activation

Develop and execute effective start-up strategies, including proactive risk mitigation

Lead UK clinical trial submissions across HRA, Ethics and MHRA

Coordinate regulatory submission packages, responses to queries and study amendments

Oversee Informed Consent Form preparation, submission and archiving

Manage site documentation, collection, validation and compliance

Maintain knowledge of UK regulations covering medicinal products, medical devices and IVDRs

Manage clinical site budgets using interactive costing tools

Support contract drafting, negotiation and implementation

Manage confidentiality agreements, indemnity and insurance documentation

Oversee site payment processes, escalations, reporting and reconciliation

Build strong relationships with clinical sites and external stakeholders

Work closely with global study teams, country teams and CRO partners

Track start-up progress, identify risks and drive timely site activation

Ensure activities remain aligned with global study strategies and timelines

If you're keen to join an exceptional team offering the opportunity to lead UK clinical study start-up activities across complex clinical trials, 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