Study Start Up Lead

Talentmark; Welwyn Garden City; Hybrid; GBP 69,000 - 92,000; Full time

Job summary

Talentmark is recruiting a Study Start Up Lead for a 6-month contract in the pharmaceutical sector. The role is hybrid with 2 days on site in Welwyn Garden City and 3 days at home.

You will lead the UK country strategy for study start-up, drive efficiency, oversee start-up operations and ensure site openings stay on track and compliant. You will manage regulatory submissions (HRA, Ethics, MHRA) and liaise with Ethics Boards and Health Authorities.

Qualifications

• Experience running clinical trial start-up and regulatory submissions.
• Strong understanding of ICH-GCP and EU CTR.
• Experience with UK systems IRAS, CPMS, iCT and ARSAC.
• Ability to lead teams through complex, fast-changing work.

Responsibilities

• Lead the country strategy for study start-up.
• Drive efficiency and work well with stakeholders.
• Oversee start-up operations; ensure sites open on time and stay compliant.
• Lead UK clinical trial submissions (HRA, Ethics, MHRA) and manage amendments.
• Oversee Informed Consent Forms from prep to submission and archiving.
• Plan and manage site budgets and contracts using iCT.

Skills

Leadership

Regulatory submissions

Stakeholder management

Communication

Team leadership

Education

Bachelor's degree in life sciences

Postgraduate/master's degree

Tools

IRAS

CPMS

iCT

ARSAC

Job description

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.

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.