Job Description:

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.