Role: Clinical Study Start Up Lead
Location: Welwyn - Hybrid (2/3 days in office)
Hours: Full-time
Pay: .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 .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.
