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
Salary description
£339.00 - £500.00 per day