James Goulding

Profile

James has been a Clinical Trials Manager since 2016, overseeing the research portfolio of LIRMM and bringing over 20 years of experience in clinical research within Leeds. His previous roles have included Clinical Trials Coordinator in Rheumatology at Chapel Allerton Hospital and Regulatory Officer in non-surgical oncology at St James’s University Hospital and Cookridge Hospital. James joined the University in 2011, having previously completed a History degree at the University of Warwick in 2004 before later obtaining an MSc in Clinical Trials from the University of Edinburgh.

James is responsible for the strategic oversight and operational delivery of research activities across the Institute, covering rheumatology, trauma, and elective orthopaedics. He leads the Clinical Trials Administrative Team with line management responsibility. A key aspect of his role is ensuring the highest standards of Good Clinical Practice (GCP) are maintained across a diverse portfolio of more than 100 academic, commercial, and non-commercial studies, working closely with clinicians, research nurses, and trial administrative staff.

Throughout his career, James has collaborated with multiple NHS Trusts across Yorkshire, developing strong relationships with Chief Investigators, Clinical Trials Units, and key NHS support services. He also helps lead activities relating to internal and external audits and inspections, ensuring compliance with regulatory requirements and maintaining standards expected by organisations such as the MHRA. Supporting continuous quality improvement and research governance across the Institute remains a central component of the role.

Key Responsibilities include:

• Providing strategic and operational oversight of the full LIRMM research portfolio, including investigator-initiated and commercially sponsored studies.

• Managing the Clinical Trials Administrative Team and providing leadership, guidance, and line management support to Project Managers, Clinical Trial Coordinators and Clinical Trial Assistants.

• Supporting the strategic development and growth of the research portfolio through feasibility assessment and study review.

• Chairing the LIRMM Trial Management Group and contributing to key research governance committees.

• Ensuring compliance with ICH-GCP standards and leading quality improvement, CAPA, and risk mitigation activities.

• Overseeing appraisals, performance reviews, staff development, and regular one-to-one meetings.

• Monitoring clinical trial management systems, recruitment performance, and compliance metrics i.e. EDGE and Q-Pulse.

• Maintaining and developing the Quality Management System, including SOP development and implementation.

• Providing expert guidance on research governance, regulatory compliance, and clinical research legislation including ICH-GCP R3 and the EU Directive.

Responsibilities

• LIRMM Portfolio Trials Manager
• LIRMM Trial Management Group
• LIRMM / CAH CSU Feasibility Core Member

Research interests

• Rheumatology, in particular inflammatory arthritis where I have previously set-up and opened multiple clinical trials, many involving academic-led protocols involving investigational medicinal products. I enjoy when the research comes full circle understanding from the clinical team the benefits research participants have experienced from access to drugs or treatment they wouldn’t ordinarily be able to obtain. I also enjoyed working for 5 years in non-surgical oncology at the Yorkshire Cancer Research Network (YCRN) in collaboration with seven different NHS Trusts across Yorkshire including: Leeds; Mid-Yorks; Harrogate; York; Huddersfield; Airedale & Bradford
• MSc dissertation comparison of the TACT and TACT2 oncology trials: 'What impact does adjuvant breast cancer chemotherapy-associated toxicity have on patients' quality of life? An analysis of the TACT2 trial dataset'
• Working group for the publication of ‘PROspectiVe imaging research DEsign and coNducT’ (PROVIDENT): Considerations for clinical trials and studies using imaging

Qualifications

• MSc in Clinical Trials
• BA (Hons) in History & Sociology

Professional memberships

• PRINCE2 Practitioner

Research groups and institutes

• Leeds Institute of Rheumatic and Musculoskeletal Medicine