Full job descriptionRole: 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 between 8:30am - 5:00pm.