Senior Clinical Trial Manager

Talentmark; Welwyn; On-site; GBP 60,000 - 80,000; Full time

Job summary

Talentmark seeks a qualified professional to lead the country strategy for study start-up in the UK. You will drive efficiency, oversee start-up operations, and ensure timely site openings while maintaining compliance.

You will manage UK clinical trial submissions (HRA, Ethics, MHRA) and amendments, oversee Informed Consent Forms, and plan site budgets and contracts with the interactive costing tool (iCT). Collaboration with ethics boards and health authorities is essential.

Qualifications

• Experience running clinical trial start-up and regulatory submissions.
• Good knowledge of UK systems like IRAS, CPMS, iCT and ARSAC.
• Solid understanding of ICH-GCP, EU CTR, and local regulations.
• Strong communication skills and the ability to lead teams through complex, fast-changing work.

Responsibilities

• Lead the country strategy for study start-up and drive efficiency with stakeholders.
• Oversee start-up operations to ensure sites open on time and stay compliant.
• Lead UK clinical trial submissions (HRA, Ethics, MHRA) and 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 iCT tool.
• Liaise with Ethics Boards and Health Authorities on trial policies.

Skills

Leadership

Communication

Education

Life sciences degree

Masters degree bonus

Tools

IRAS

CPMS

iCT

ARSAC

Job description

• 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.