Location
London

Hours
Full Time (hours not specified)

Salary
£56,276 per annum

About the Role
The Clinical Trials Start Up Specialist will play a key role in ensuring the successful and timely initiation of both commercial and non-commercial clinical trials within the department. Responsibilities include contributing to the feasibility process by attending site selection visits, assisting with feasibility questionnaires, and providing input into Trials Adoption Feasibility Forms (TAFFs). You will review and develop systems to support negotiation of commercial contracts with clinical departments such as pharmacy, pathology, and radiology. Close collaboration with KHP-CTO and Trust R&D is essential to facilitate smooth trial set-up processes.

You will conduct financial reviews of commercial trial budgets to ensure viability, assess non-commercial agreements and funding, and complete capacity and capability assessments. Financial negotiations with commercial companies, clinical research organisations, and Trust Investigators will be part of your remit. Building strong working relationships with key stakeholders and coordinating with support departments, research teams, investigators, and Trust R&D/KHP-CTO will ensure trials open on time and meet targets.

In addition, you will assist with Investigator-Led clinical trial set-up and research agreement development. Leadership responsibilities include managing and supporting staff within the management support team, identifying training needs, and implementing Trust HR policies. You will line manage the OHCT Imaging Coordinator and a team of data managers, providing guidance on all aspects of clinical trial set-up.

Research management duties include coordinating submissions for Ethics Committee, R&D Committee, and Joint Clinical Trials Office approvals, identifying inefficiencies in trial initiation, overseeing amendments, and acting as a resource on regulatory matters. You will attend relevant meetings, lead audits and evaluations, and support data collation from clinical trials.

Effective communication is vital, as you will liaise with internal and external groups to provide advice, negotiate information, present data, and promote the research team’s work. You will also assist with IT system implementation to support research processes.

Professional development is encouraged through training programmes and ongoing education, with regular performance reviews and adherence to Trust policies throughout the team.

Experience
- Proven experience in clinical trial set-up and management, including commercial and non-commercial trials.
- Experience in financial review and negotiation of clinical trial budgets and agreements.
- Leadership experience managing and supporting teams.
- Knowledge of research governance, ethics submissions, and regulatory requirements.
- Ability to coordinate complex projects and work with multiple stakeholders.

About you
- Strong organisational and communication skills.
- Professional integrity, tenacity, and the ability to motivate and develop staff.
- Ability to work collaboratively with internal departments and external partners.
- Proactive approach to identifying and resolving issues.
- Commitment to continuous professional development and adherence to policies.

Qualifications
- Relevant qualifications or equivalent experience in clinical research or related fields.
- Evidence of ongoing professional development in clinical trials or research management.