Clinical Operations Lead

Talentmark; Welwyn Garden City; On-site; GBP 70,000 - 92,000; Full time

Job summary

Talentmark is seeking a Study Start Up Lead for a 6-month hybrid contract in Welwyn Garden City. The role combines on-site and remote work and focuses on leading UK study start-up, regulatory submissions, and site readiness. You will coordinate with ethics boards and health authorities and manage start-up budgets and contracts, using iCT for costing and planning.

Qualifications

• Life sciences degree required; postgraduate a bonus.
• Experience running clinical trial start-up and regulatory submissions.
• Strong knowledge of UK systems: IRAS, CPMS, iCT, ARSAC.
• Solid understanding of ICH-GCP, EU CTR, and local regs.
• Excellent communication and leadership in fast-changing environments.

Responsibilities

• Lead the country strategy for study start-up and drive efficiency.
• Oversee start-up operations to ensure sites open on time and stay compliant.
• Lead UK clinical trial submissions (HRA, Ethics, MHRA) and manage amendments.
• Oversee Informed Consent Forms from preparation to submission and archiving.
• Plan and manage site budgets and contracts, including iCT use.
• Liaise with Ethics Boards and Health Authorities on trial policies.

Skills

Strong communication

Team leadership

Regulatory liaison

Education

Life sciences degree

Postgraduate/master's degree (bonus)

Tools

IRAS

CPMS

iCT

ARSAC

Job description

Role Details

Talentmark are recruiting for a Study Start Up Lead to join a company in the pharmaceutical industry on a contract basis for 6 months. This role is hybrid, with 2 days per week on site in Welwyn and 3 days home working.

Company

Our client is one of the world's premier innovative biopharmaceutical companies, discovering, developing and providing over 160 different medicines, vaccines and consumer healthcare products to help improve the lives of millions of people in the UK and around the world every year.

This role is hybrid, with 2 days per week on site in Welwyn and 3 days home working.

Salary

Up to £376.97 per day PAYE or up to £500 per day Umbrella.

Study Start Up Lead Role

• Lead the country strategy for study start-up. Drive efficiency and work well with stakeholders.
• Oversee start-up operations. Make sure sites open on time and stay compliant.
• Lead UK clinical trial submissions, such as HRA, Ethics and MHRA. Manage amendments as studies progress.
• Oversee Informed Consent Forms, from preparation to submission and archiving.
• Plan and manage site budgets and contracts, including using the interactive costing tool (iCT).
• Liaise with bodies like Ethics Boards and Health Authorities on trial policies.

Your Background

• A life sciences degree or equivalent. A postgraduate or master's degree is a bonus.
• Experience running clinical trial start-up and regulatory submissions.
• Good knowledge of UK systems like IRAS, CPMS, iCT and ARSAC.
• A solid understanding of ICH-GCP, EU CTR, and local regulations.
• Strong communication skills and the ability to lead teams through complex, fast-changing work.

It is essential that applicants hold entitlement to work in the UK.

Please note: This role may be subject to a satisfactory basic Disclosure and Barring Service (DBS) check.