Clinical Trials Unit Manager inBristol inBristol PUBLISHED 23 APR 2024

Job summary

The Cancer Clinical Trials Unit in the Bristol Haematology & Oncology Centre (BHOC) is seeking an experienced and dynamic research manager to lead the strategic development of the CTU and provide day-to-day management of the unit and oversight of our UK collaborating sites.

Based in central Bristol, the CTU has grown considerably over the past decade and manages a substantial portfolio of NIHR and commercial trials. The unit is focused on transformative therapies to make a meaningful difference in people's lives, including immune effector cells, solid tumour trials and our investigator-led portfolio.

The role is an exciting opportunity to make an impact in terms of both research development and patient care on day-to-day basis by offering more patients the opportunity to access innovative new drugs and treatments.

We are looking for a natural team leader with a passion for clinical development and an ability to work in partnership with our clinical teams to ensure research is at the centre of the care we deliver.

Main duties of the job

Management of Adult Oncology/ Haematology and Adult Bone marrow Transplant Clinical Trials within University Hospital Bristol and Weston BHS Trust (UHBW) and for trials that span across local trusts, South West collaborating sites and nationally across the UK when BHOC are the lead investigator site for Investigational Medicinal Product Multi-Centre Trials.

Operational planning and management of a substantial trials portfolio consisting of 150-200 clinical trials; with approximately 90-100 trials open to recruitment, 20-30 in set-up and a large proportion in follow-up at any one time. This involves approximately 1,000 patients being managed within a clinical trial and 900-1000 new referrals for trial entry per year

Overall decision making regarding the complexity, nature, and level of trial activity the unit can support and ultimately manage associated risks; clinical, financial and reputational.

Managing CTU capacity and balancing trial demand through collaboration with site specific leads/ individual principle Investigators and clinical support departments regarding trial portfolio development.

Managing the department's budget - staff salaries, income targets and grant funding.

Management of an integrated team of research professionals; research nurses/radiographers, trial co-ordinators/officers and administrators

About us

University Hospitals Bristol and Weston NHS Foundation Trust (UHBW) is one of the largest acute Trusts in the country, bringing together a combined workforce of over 13,000 staff and over 100 different clinical services across 10 different sites, serving a core population of more than 500,000 people across South West England. UHBW has been rated by the CQC as 'Good' overall and our staff are proud to deliver excellent care to the people of Bristol, Weston and beyond. As a forward- thinking multi-award winning Trust and a digital exemplar committed to improving patient care, our world-leading research and innovations are having a positive local and global impact. Our hospitals are spread across Bristol and Weston, join us and you can enjoy the very best of both worlds; city living within a stone's throw of the countryside or beside the seaside, both with easy access to all that the South West has to offer. UHBW is committed to safeguarding and promoting the welfare of children, young people and vulnerable adults. As an equal opportunities employer actively working towards a diverse workforce we aim to recruit and retain a workforce which represents the rich diversity of the local population at all levels and are committed to designing our services around the needs of individual patients and those around them. Anonymous information will be used from your application in order to ensure we're meeting our pledge.

Job description

Job responsibilities

For a more detailed job description, main responsibilities, and Person Specification, please refer to the job description document attached to this vacancy.

Job description
Job responsibilities

For a more detailed job description, main responsibilities, and Person Specification, please refer to the job description document attached to this vacancy.

Person Specification

Qualifications and Training

Essential

• Relevant Master's degree or equivalent

Desirable

• Professional Qualification with current professional clinical Registration

Knowledge and Experience

Essential

• Substantial experience of both commercial and non-commercial clinical research management
• Substantial experience of multi-disciplinary staff management and research skill mixing within a matrix environment
• Extensive clinical, organisational and managerial skills
• Ability to demonstrate clinical expertise and sound knowledge of clinical issues providing expert advice on clinical trial decision making
• In-depth knowledge and experience of NHS Research and Development requirements
• A thorough understanding of the national Research & Development agenda
• Extensive experience of developing a clinical unit
• In-depth knowledge of the regulations involved early phase trials
• Experience and knowledge of national site set-up (multiple) to ICH GCP standards and experience of pharmacovigilance and the EU requirements for safety reporting

Desirable

• Experience of working outside the NHS in a commercial research environment

Skills and Abilities

Essential

• Highly developed communication / interpersonal skills
• Autonomous decision making and judgements involving complex situations
• Multi-disciplinary team management and development
• Collaboration and influencing skills within a matrix environment
• Prioritisation of work streams and responding to new circumstances rapidly
• Ability to plan strategically for service development within organisational boundaries
• Negotiation skills across complex organisations with both NHS and commercial partners
• Project management skills
• Process development and management of research performance and metrics
• Budget management, invoicing and resource planning

Aptitudes

Essential

• Managing a demanding and constantly shifting workload e.g. ability to maintain patient trial activity/recruitment targets by effectively utilising the given research workforce during times of shortage
• Ability to work as part of a multi-disciplinary team
• High levels of personal credibility, presentation and self-awareness
• Attention to detail
• Integrity and impartiality

Person Specification
Qualifications and Training

Essential

• Relevant Master's degree or equivalent

Desirable

• Professional Qualification with current professional clinical Registration

Knowledge and Experience

Essential

• Substantial experience of both commercial and non-commercial clinical research management
• Substantial experience of multi-disciplinary staff management and research skill mixing within a matrix environment
• Extensive clinical, organisational and managerial skills
• Ability to demonstrate clinical expertise and sound knowledge of clinical issues providing expert advice on clinical trial decision making
• In-depth knowledge and experience of NHS Research and Development requirements
• A thorough understanding of the national Research & Development agenda
• Extensive experience of developing a clinical unit
• In-depth knowledge of the regulations involved early phase trials
• Experience and knowledge of national site set-up (multiple) to ICH GCP standards and experience of pharmacovigilance and the EU requirements for safety reporting

Desirable

• Experience of working outside the NHS in a commercial research environment

Skills and Abilities

Essential

• Highly developed communication / interpersonal skills
• Autonomous decision making and judgements involving complex situations
• Multi-disciplinary team management and development
• Collaboration and influencing skills within a matrix environment
• Prioritisation of work streams and responding to new circumstances rapidly
• Ability to plan strategically for service development within organisational boundaries
• Negotiation skills across complex organisations with both NHS and commercial partners
• Project management skills
• Process development and management of research performance and metrics
• Budget management, invoicing and resource planning

Aptitudes

Essential

• Managing a demanding and constantly shifting workload e.g. ability to maintain patient trial activity/recruitment targets by effectively utilising the given research workforce during times of shortage
• Ability to work as part of a multi-disciplinary team
• High levels of personal credibility, presentation and self-awareness
• Attention to detail
• Integrity and impartiality

Disclosure and Barring Service Check

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Certificate of Sponsorship

Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the .

From 6 April 2, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. .

Additional information
Certificate of Sponsorship

Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the .

From 6 April 2, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. .

Employer details

Employer name

University Hospitals Bristol and Weston NHS Foundation Trust (UHBW)
Address

Bristol Haematology & Oncology Centre (BHOC)

Horfield Rd,

Bristol

BS2 8ED

Employer's website