Clinical Study Start Up Lead

Clearline Recruitment Ltd; Welwyn; Hybrid; GBP 70,000 - 110,000; Full time

Benefits offered by this job

Free on-site parking

Opportunity to support complex UK clin

Exposure across multiple therapeutic

Job summary

Clearline Recruitment Ltd has an excellent opportunity for a Clinical Study Start Up Lead to join a global healthcare organisation in the UK. You will drive start-up strategy, regulatory submissions, site activation, contracts and budgets, collaborating with clinical sites, internal teams and external partners.

This country- and site-facing role requires strong UK start-up experience and the ability to lead within complex, matrixed teams across HRA, Ethics and MHRA processes.

Qualifications

• Strong and recent UK clinical trial start-up experience.
• Experience taking studies through site set-up to site activation.
• Strong knowledge of UK regulatory submissions (HRA, Ethics and MHRA).
• Experience with UK start-up systems (IRAS, CPMS, iCT, ARSAC).
• Experience with clinical site contracts, budgeting and negotiations.
• Solid understanding of ICH-GCP, EU CTR and UK regulatory requirements.
• Experience managing site relationships and cross-functional teams.
• Experience managing vendor/CRO relationships.

Responsibilities

• Lead the UK country strategy for clinical study start-up.
• Drive start-up activities from planning through site activation.
• Develop and execute start-up strategies with proactive risk mitigation.
• Lead UK clinical trial submissions across HRA, Ethics and MHRA.
• Coordinate submission packages, queries and amendments.
• Oversee Informed Consent Form preparation and archiving.
• Manage site documentation and compliance.
• Maintain knowledge of UK regulations for medicines/devices/IVDRs.
• Manage site budgets using interactive costing tools.
• Support contract drafting, negotiation and implementation.
• Manage confidentiality agreements and insurance documentation.
• Oversee site payment processes, escalations and reporting.
• Build strong relationships with clinical sites and CROs.

Skills

UK start-up experience

Site activation

Regulatory submissions

Cross-functional leadership

Vendor/CRO relationships

Regulatory coordination

Problem-solving

UK regulatory knowledge

Tools

IRAS

CPMS

iCT

ARSAC

Veeva Vault

CTIS

RIM

Job description

Location: Welwyn - Hybrid (2/3 days in office)

Hours: Full-time

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.

• 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
• 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