Study Start Up Lead

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.

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.

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

• 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.

• 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.