Trial Manager in Leicester

Come and join a large, experienced and dynamic research management team at the Leicester Diabetes Centre. We are looking for an ambitious Trial Manager to support the set‑up, management and delivery of research studies and clinical trials in diabetes and other long‑term health conditions. The Leicester Diabetes Centre is one of the largest facilities in Europe for conducting high‑quality clinical research in diabetes and other long‑term health conditions. We are committed to improving the lives of people living with these conditions through innovative research and evidence‑based practice.

Main duties of the job:

• You will join a team of research administrators, trial coordinators and trial managers working across single‑ and multi‑site studies.
• Your role will be to ensure that allocated studies receive timely and appropriate oversight to reach time and target, using diplomacy and strong communication skills to manage challenges along the way.
• The role may involve travel across the East Midlands to support research sites.
• You will be expected to line‑manage one or more administrative staff and may supervise the work of a Trial Coordinator.
• Please note that this role requires regular on‑site attendance.

Job responsibilities:

• This is an excellent opportunity for someone with trial management or coordination experience who enjoys a challenge, uses their initiative, and can adapt to the changing demands of research.
• You will need to be self‑motivated, an effective communicator, and confident working both independently and as part of a wider team.
• Timely set‑up of studies, providing input into study protocols, IRAS forms, patient and GP facing documentation, case report forms, remote data entry systems and all associated documentation as relevant to role.
• Set up participating sites by undertaking site initiation visits, remotely and/or in person as necessary.
• Identify and undertake feasibility of sites, ensuring all participating sites have received relevant trial specific training.
• Facilitate approvals for sites to open to recruitment and monitor progress of each trial site and take appropriate action.
• Efficient and effective set‑up and maintenance of internal study management systems.
• Time and target delivery of studies.
• Management of study recruitment which will include the development of recruitment plans and the leadership of recruitment strategies for example community events, leaflet drops etc.
• Timely and accurate reporting of study progress, finance, and study related reporting (i.e., protocol deviations, serious adverse event, and adverse event reporting).
• Efficient and effective set‑up and maintenance of trial master file including all financial paperwork to permit clear audit trail of spend.
• Facilitate meetings of trial committees and be responsible for ensuring relevant and timely updates for project stakeholders.
• Develop and maintain good working relationships across the department.
• Efficient and effective staff training for study related procedures.
• Motivate, develop, and support staff that the post holder line manages.

Training and Qualifications:

• Degree or equivalent qualification in a science or health related discipline or a degree in another field with experience in clinical trials or project management or significant equivalent experience in a relevant field.
• Leadership qualification at certificate level or equivalent experience.
• Higher degree qualification (e.g., MSc) in clinical trials or a health‑related discipline.
• Project Management Qualification.

Experience:

• Minimum of 2 years' experience of running or delivering clinical research studies/trials.
• Experience of working in a large complex multi professional organisation.
• Must have experience within a supervisory/management role.
• Sound knowledge of the principles of research governance and ICH‑GCP.
• Experience of creating research ethics applications including all supporting documentation and knowledge of HRA and MHRA application process and requirements including experience of applying for substantial amendments to the study protocol.
• Facilitation and communication skills both written and verbal appropriate to the project.
• Experience of managing a budget.
• Previous NHS experience or Higher Education Institution.

Communication and Relationships Skills:

• Excellent communication skills written and verbal – able to communicate at all levels with well‑developed networking and influencing skills.
• Ability to work autonomously.
• Ability to work effectively within and direct a team or individual team members.

Analytical and Judgement Skills:

• Demonstrate consistent level of attention to detail in relation to study documentation and data collection and inputting.
• Competent with Microsoft software (e.g., Word, Excel and Powerpoint).

Skills:

• Leadership and motivational qualities.
• Planning and organisational skills, with a methodical approach and the ability to pay attention to detail.
• Ability to work to deadlines/stability under pressure.
• Ability to use initiative.
• High level of computer literacy.
• Ability to prioritise own and others workload and practice effective time management.
• Excellent presentation skills.
• Understand, interpret and critically analyse data and information and prepare progress reports.
• Understand and use quality management systems.
• Actively manage own personal development.
• Understand and use project management tools.

Planning and Organisation Skills:

• Project Management Skills.
• Ability to work to multiple conflicting deadlines.
• Experience in creating a Gantt chart and recruitment charts.
• Experience in report writing.
• Experience in budget management.

Physical skills:

• Ability to travel to other sites within UHL and across UK with some international travel expected.

Equality, Diversity and Inclusion:

• Able to demonstrate a commitment to and understanding of the importance of treating all individuals with dignity and respect appropriate to their individual needs.
• All staff are expected to engage in compassionate and inclusive leadership in the provision of high quality care and interactions with others.

Other requirements specific to the role:

• Ability to work flexibly.
• Ability to work as part of a team.
• Reliable and credible in the role.

Commitment to Trust Values and Behaviours:

• Must be able to demonstrate behaviours consistent with the Trust's Values and Behaviours.

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.