Clinical Study Start Up Lead

Clearline Recruitment Ltd; Welwyn Garden City; Hybrid; GBP 55,000 - 92,000; Full time

Benefits offered by this job

Hybrid working

Free on-site parking

6-month contract opportunity

Job summary

Clearline Recruitment Ltd is seeking a Clinical Study Start Up Lead to join a global healthcare organisation on a 6-month contract in the UK, hybrid in Welwyn. The role focuses on start-up activities, regulatory submissions and vendor management.

You will drive UK country strategy for study start-up, coordinate HRA, Ethics and MHRA submissions, and oversee site activation across multiple sites and teams.

Qualifications

• Strong and recent UK clinical trial start-up experience.
• Experience taking studies through site set-up to activation.
• Knowledge of UK submissions (HRA, Ethics, MHRA).
• Experience with UK start-up systems IRAS/CPMS/iCT/ARSAC.
• Experience with site contracts, costing templates, budgets & negotiations.
• Understanding of ICH-GCP, EU CTR and UK regulatory requirements.
• Experience managing site relationships and cross-functional teams.
• Experience managing vendor and CRO relationships.
• Knowledge of amendments and regulatory coordination throughout lifecycle.
• Postgraduate qualification desirable.

Responsibilities

• Lead UK country start-up strategy and drive activities from planning to site activation.
• Develop and execute start-up strategies with risk mitigation.
• Lead UK submissions across HRA, Ethics and MHRA.
• Coordinate regulatory submission packages and responses to queries.
• Oversee ICF preparation, submission and archiving.
• Manage site documentation, validation, and compliance.
• Monitor UK regulations for medicinal products, devices and IVDRs.
• Oversee site budgets using costing tools.
• Support contract drafting, negotiation, and implementation.
• Manage confidentiality, indemnity and insurance documentation.
• Oversee site payments, escalations, reporting, and reconciliation.
• Build relationships with clinical sites and CRO partners.
• Coordinate with global study teams and country teams.

Skills

UK clinical trial start-up experience

Site management

Regulatory coordination

Vendor/CRO management

Cross-functional collaboration

Problem-solving

Communication

Attention to detail

Education

Degree in Life Sciences or equivalent

Tools

IRAS

CPMS

iCT

ARSAC

Veeva Vault

CTIS

RIM

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.

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

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