Head of Trials Office Job Glasgow Scotland UK,Healthcare

Position: Head of Trials Support Office

Job Purpose

To play a key role in the development of the University’s clinical and pre‑clinical research strategy by contributing specialist regulatory knowledge, in conjunction with University Senior Management. To provide an end‑to‑end, high‑level service in relation to the provision of specialist research support to university staff and students.

To represent the University in discussions with senior NHS and industry colleagues to ensure a robust, collaborative and strategic framework for the conduct and management of innovative research is maintained and developed.

Input into strategies to enhance the conduct and management of Clinical Trials of Investigational Medicinal Products, Medical Device/Invitro Medical Device Trials, Human Data and Data Linkage studies, studies involving Human Tissue, and relevant pre‑clinical studies.

Lead the development and implementation of University wide research governance systems including the management and development of clinical and pre‑clinical research support staff, staff from other relevant University, College and support services and the NHS as required.

To establish a culture of continuous improvement for the effective and efficient research management service in the College and the wider University community, by managing support for the University’s research involving human participants in close working partnership with senior leaders across the University.

Main Duties and Responsibilities

Develop the processes in place to ensure the University’s responsibilities are met with respect to the Medicines for Human Use Act, the UK Policy Framework for Health and Social Care Research, the Human Tissue Act, the Human Fertility and Embryology Act, the General Data Protection Regulation, the Freedom of Information Act, and all other relevant UK and international legislation relating to research involving humans, human tissue and data.

Lead, anticipate, identify trends and react to developing and emerging UK, EU and international legislation ensuring all institutional risks are identified ensuring appropriate risk mitigation strategies are established and put in place when required in a timely fashion.

Direct, manage and be accountable for the regulatory compliance of College trials and research‑support infrastructure (pre‑clinical, clinical & laboratory), ensuring an efficient and effective service is delivered in alignment with College and University research strategy.

Responsible for and lead all operational aspects of relevant regulatory audits and inspections including MHRA GCP, MHRA GLP, Human Tissue Authority inspections, Home Office inspections, and internal or external audits relating to human, tissue, data and animal research.

Responsible for assessing risk and national or international impact of all new clinical and relevant pre‑clinical research projects and initiatives. To provide advice and expert advice to senior management on the University’s involvement in such projects.

Provide a focus for the provision of information and advice on all aspects of regulatory compliance and research governance to College staff, the wider University community as well as NHS and industry colleagues as required.

Represent the College of MVLS and act as the point of contact for, and with, the University Services Research Support Office to ensure that the best interests of the College and University are served, with best value attained on behalf of the College and University in relation to research involving humans, their tissue and/or data and relevant pre‑clinical studies.

To provide expert advice to the Chairs and Co‑Chairs of relevant College, University and NHS Research Ethics Committees as required.

Maintain up to date knowledge of the requirements of UK and International external organisations such as governmental agencies, major charities and funding bodies in relation to research involving clinical and relevant pre‑clinical research.

Provide support and leadership in the development of significant and strategically important clinical and pre‑clinical research projects, including drafting key sections of funding applications and/or clinical protocols, collation of…