Overview
A position has arisen for a Senior Trial Manager, equivalent to Senior Research Fellow (Grade 9) or Research Fellow (Grade 8), based in the Sheffield Clinical Trials Research Unit (CTRU).
Sheffield CTRU has received substantial infrastructure funding to grow and diversify its portfolio of multi-centre cancer clinical trials. The post holder will be responsible for trial design, grant development, and submission, as well as oversight of Quality Assurance and senior-level study implementation, with a specific focus on oncology-based CTIMPs (Clinical Trials of Investigational Medicinal Products) as part of the Sheffield Oncology Clinical Trials Infrastructure Programme (SOCTIP). You will work closely with the CTRU Academic Lead for Oncology, CTRU staff and Chief Investigators to secure research funding and ensure that studies under your supervision are implemented in accordance with randomised controlled trial scientific principles, the study protocols, and regulatory standards.
You will provide oversight of all CTRU input into the specialist oncology studies within your portfolio, ensuring that all services provided by the Unit are compliant with professional, national, and international regulatory frameworks.
Whilst the post is funded fixed term until March 2031, if successful, it is envisaged that the position will be income generating and so funded on an ongoing basis beyond this.
Experience of project-managing large, multi-centre clinical trials is essential. We are seeking a candidate with a proven track record of working within the oncology research field, possessing a deep understanding of the Medicines for Human Use (Clinical Trials) Regulations as they apply to complex cancer research.
Main duties and responsibilities
- Portfolio Management: Support the CTRU Director and Academic Lead for Oncology in the strategic delivery of the Sheffield Oncology Clinical Trials Infrastructure Programme (SOCTIP).
- Trial Delivery: Responsible for overseeing the set-up, coordination, and delivery of large multi-site clinical trials, including protocol development, obtaining regulatory approvals (IRAS/MHRA), and site initiation.
- Leadership (G9): Lead the development of a specialist oncology research portfolio, taking a primary role in designing studies and securing large research grants.
- Support & Advice (G8): Provide expert advice and support to researchers developing new funding proposals, specifically regarding trial design, resource costing, drug procurement and project management timelines.
- Regulatory & Quality Assurance: Oversee Quality Assurance processes and ensure compliance with the Medicines for Human Use (Clinical Trials) Regulations 2004, GCP, and data protection requirements.
- Staff Supervision: Supervise Trial Managers and study-specific staff, providing mentorship and guidance on trial implementation.
- Research Output (G9): Lead the preparation of papers for high-impact oncology and academic journals and present findings at international conferences.
- Research Output (G8): Contribute and lead to academic papers and the dissemination of research findings through reports and publications.
Person Specification
Our diverse community of staff and students recognises the unique abilities, backgrounds, and beliefs of all. We foster a culture where everyone feels they belong and is respected. Even if your past experience doesn't match perfectly with this role's criteria, your contribution is valuable, and we encourage you to apply. Please ensure that you reference the application criteria in the application statement when you apply.
Grade 8 (Research Fellow)
Grade 9 (Senior Research Fellow)
Essential: Postgraduate qualification or equivalent experience in a relevant health-related or methodological area
Essential: Postgraduate qualification in a relevant health-related or methodological area.
Essential: Experience in trial set-up and delivery for large, multi-centre CTIMPs.
Essential: Proven track record of managing large, multi-centre oncology CTIMPs from setup to close-out.
Desirable: Research experience within the oncology field.
Essential: Extensive experience and deep understanding of cancer-specific trial complexities.
Essential: Experience coordinating Clinical Trials of Investigative Medicinal Products (CTIMPs).
Essential: Extensive
experience working on complex Oncology CTIMPs and oncology pharmacovigilance.
Essential: Experience supporting the writing of grant applications and coordinating expertise for proposals.
Essential: Proven track record of successfully securing major research grants (e.g., NIHR, CRUK, MRC).
Desirable: Experience in substantial contribution to papers of clinical trials in academic journals, including some as first author.
Essential: Strong track record of high-quality, peer-reviewed research papers of clinical trials in high-impact oncology journals.
Essential: Experience in supervising/coordinating study staff and motivating a team.
Essential: Experience in supervising Trial Managers and mentoring early-career researchers.
Further Information
Grade 8 £48,822-£65,509
Grade 9 £61,759-£80,254
Full-time / Part-time (a minimum of 0.6FTE)
Hybrid
Fixed Term until 31st March 2031
CTRU Academic Lead for Oncology Trials
Trial Managers
Study Managers
Research Assistants
https://sheffield.ac.uk/ctru
For informal enquiries about this job contact Prof Matt Hammond, Director of the Sheffield Clinical Trials Research Unit: on
[email protected]
Next steps in the recruitment process
It is anticipated that the selection process will take place in September. This will consist of a 10 minute presentation and subsequent interview. If you need any support, equipment or adjustments to enable you to participate in any element of the recruitment process you can contact
[email protected].
Our vision and strategic plan
We are the University of Sheffield. This is our vision: sheffield.ac.uk/vision ().
What we offer
- A minimum of 41 days annual leave including bank holiday and closure days (pro rata) with the ability to purchase more.
- Flexible working opportunities, including hybrid working for some roles.
- Generous pension scheme.
- A wide range of discounts and rewards on shopping, eating out and travel.
- A variety of staff networks, providing opportunities for social interaction, peer support and personal development (for example, Race Equality, LGBT+, Women’s and Parent’s networks).
- Recognition Awards to reward staff who go above and beyond in their role.
- A commitment to your development access to learning and mentoring schemes; integrated with our Academic Career Pathways
- A range of generous family-friendly policies
- paid time off for parenting and caring emergencies
- support for those going through the menopause
- paid time off and support for fertility treatment
- and more
We are a Disability Confident Employer. If you have a disability and meet the essential criteria for this job you will be invited to take part in the next stage of the selection process.