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