Head of Trials Support Office

Job Description

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

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.
8. To provide expert advice to the Chairs and Co Chairs of relevant College, University and NHS Research Ethics Committees as required.
9. 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.
10. 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 data and project management of process including coordination between key external and internal stakeholders and partners.
11. Determine and recommend when the University should sponsor or co sponsor research projects or initiatives. Advise the University to appropriately to inform strategic and operational national and international sponsorship policy.
12. Ensure the University clinical trials insurance policy is robust and fit for purpose. Confirm that appropriate insurance/indemnity is in place in relation to the University’s clinical research portfolio and ensure insurance related costs have been considered before research is initiated within or outside the UK. Instruct the University insurance Brokers and Insurance underwriters in relation to insurance policy content and costing.
13. Be responsible for the design, implementation and successful conclusion of all clinical and relevant pre clinical research related corrective and preventative actions plans as and when required.
14. Proactively lead, network and collaborate across the University to share best practice, develop and deliver training and web based resources, as required, implementing changes and updates to exiting practice as and when required.
15. Advise College and University senior management on cases of suspected research fraud or misconduct. Conduct misconduct investigations in relation to clinical research misconduct and/or fraud as and when required.
16. To support and deliver high quality technical advice and guidance to colleagues across the University to drive consistency and best practice in research compliance.

Knowledge, Qualifications, Skills and Experience Knowledge/Qualifications Essential:

• A1 PhD or knowledge and experience in a subject relevant to the role.
• A2 Degree or equivalent in a relevant discipline with evidence of continued professional development in an area relevant to the role.
• A3 Significant and demonstrable knowledge of the Higher Education clinical and/or pre clinical research environment in a senior management capacity with managerial understanding of governance and related issues associated with University, the NHS and/or commercial research.
• A4 Established, detailed and specialist knowledge and understanding of the regulatory framework governing clinical and related pre clinical research.
• A5 Demonstrable specialist understanding of clinical laboratory quality management systems.
• A6 Working demonstrable knowledge and understanding of UK, EU and International data protection legislation.
• A7 Detailed knowledge of NHS Safe Havens and Biorepositories and their operational procedures in relation to academia and industry.

Skills Essential:

• C1 People management skills including leadership, coaching, work allocation and development.
• C2 Inter and intra project management skills.
• C3 Excellent oral and written communication skills with the ability to communicate at all levels.
• C4 Excellent organisational skills.
• C5 High degree of numeracy.
• C6 Excellent eye for detail and accuracy.
• C7 Excellent interpersonal skills incorporating excellent conflict resolution skills.
• C8 High level of influencing and negotiating skills.
• C9 Highly developed IT skills.
• C10 Ability to think strategically and provide input to strategic planning processes.
• C11 Ability to exercise initiative.
• C12 Excellent presentation skills.
• C13 Ability to work independently and as part of a team.
• C14 Ability to work flexibly and adapt to changing environments.

Experience Essential:

• E1 Established track record of providing and managing high quality professional advice services in a clinically related research environment.
• E2 Proven track record of successful people and team management.
• E3 Significant relevant senior level research administration and management experience.
• E4 Experience of providing high quality management information to inform decision and policy making.
• E5 Experience of managing a complex clinical and/or pre clinical research portfolio in a sponsor role.
• E6 Experience working at a management level in a multidisciplinary complex matrix organisation.

Terms and Conditions Salary will be Grade 9, £59,966 – £67,468 per annum.

This post is full time, 35 hours per week and open ended.

The University of Glasgow has a responsibility to ensure that all employees are eligible to live and work in the UK. If you require a Skilled Worker visa to work in the UK, you will be required to meet the eligibility requirements of the visa route to be assigned a Certificate of Sponsorship.

Please note that this post may be eligible to be sponsored under the Skilled Worker visa route if tradeable points can be used under the Skilled Worker visa rules. For more information please visit:

Benefits

• A warm welcoming and engaging organisational culture, where your talents are developed and nurtured, and success is celebrated and shared.
• An excellent employment package with generous terms and conditions including 41 days of leave for full time staff, pension, benefits and discount packages.
• A flexible approach to working.
• A commitment to support your health and wellbeing, including a free 6-month UofG Sport membership for all new staff joining the University.

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