Senior Clinical Trial Manager
Do you have excellent organisational and communication skills?
Do you want to be part of a leading team that has a national and international reputation for excellence in conducting complex, multi-centre clinical trials?
The Clinical Trials Research Unit (CTRU) within the Leeds Institute of Clinical Trials Research (LICTR) is an international leader in the field of clinical trials. The Unit is one of the largest in the UK and conducts national and international randomised and early phase clinical trials in a variety of clinical fields. Our main aim is to support the challenge of changing clinical practice for the better and our past results and current work have already helped to do this. Our results inform the academic development of this specialised field of clinical research on a national and international level. Particularly, we specialise in complex phase III trials, efficient phase I/II trials, biomarker driven designs, seamless phase II/III designs, adaptive designs and the development and evaluation of complex interventions.
You will join our team and take responsibility for coordinating specific clinical trials from set-up and recruitment through to trial closure and analysis. You will directly co-ordinate large multi-centre trials and/or lead a CTRU portfolio trial management team, ensuring international quality standards in trial management for the projects/portfolio by supervising complex trials and associated trial co-ordination staff across the therapeutic area. You will also support the dissemination of research results by contributing to high quality publications and presenting at meetings and conferences.
You will have experience of trial coordination and/or trial management gained working on interventional trials. You will also have up-to-date knowledge of legislation, regulatory and governance environment relating to clinical trials. As you will work closely, interactively and collaboratively with multiple stakeholders you will need excellent communication and interpersonal skills, along with the ability to manage and meet deadlines.
What does the role entail?
As a Senior Clinical Trial Manager your main duties will include:
- Leading the set-up, conduct and closure of multi-centre randomised controlled trials and actively contribute to the design, from a trial co-ordination, regulatory and logistics perspective;
- Managing projects, making of day-to-day decisions and highlighting critical issues to the senior team, adhering to milestones and resources outlined in the grant application and supervising and managing trial co-ordination staff;
- Maintaining a thorough and up-to-date understanding and working knowledge of legislation, guidance and local and national initiatives relating to clinical research and applying this knowledge through working practices on the projects you manage;
- Working in partnership with the Divisional Director, Principal Statistician and Head of Trial Management to develop grant applications and implement high quality randomised controlled trials;
- Establishing and maintaining professional relationships with collaborators including funders, staff from other trials units, clinicians, professors, relevant laboratory and research staff at both national and international centres;
- Actively contributing to the development of systems and processes through involvement in Working Groups and development or amendment of associated documentation;
- Contributing to high quality publications in peer-reviewed clinical and methodological journals and presenting research, and/or issues in trial design and conduct, at local, national and international meetings and conferences;
- Delivering relevant training sessions, both internally and externally. These duties provide a framework for the role and should not be regarded as a definitive list.
- Other reasonable duties may be required consistent with the grade of the post.
What will you bring to the role?
As a Senior Clinical Trial Manager you will have:
- Substantial experience in Trial Management of interventional trials in a quality assured clinical trials environment or substantial experience of leading and implementing research across several organisations;
- Knowledge of the regulatory and governance environment in the UK and other relevant guidance, for example Consolidated Standards of Reporting Trials CONSORT, and experience of implementing within projects;
- Confidence, experience and the ability to lead and participate constructively in complex multi-disciplinary meetings and decision making processes with strategic thinking and an inquisitive mind;
- The ability to assimilate information and reproduce it in a clear, consistent, accurate and relevant manner according to purpose and audience;
- Previous experience supervising or line managing people, with the ability to work effectively in a team assuming responsibility, leading projects and making decisions within the sphere of the role;
- The ability to build professional working relationships with internal and external staff, using with effective negotiation, diplomacy and influencing skills;
- A high level of organisational, planning and self-management skills, including the ability to manage and meet multiple deadlines and deliver projects across several organisational boundaries and handle problems, efficiently and effectively, using own initiative;
- A commitment to upholding University values and taking ownership for personal development.
You may also have:
- Experience of trial management within a relevant area; Clinical Trials of Investigational medicinal Products CTIMP, surgery, device or Complex intervention.
Find out more about the Clinical Trials Research Unit.
Find out more about the Faculty of Medicine and Health.
Find out more about Athena Swan in the Faculty of Medicine and Health.
Working at Leeds
Find out more about the benefits of working at the University and what it's like to live and work in the Leeds area on our Working at Leeds information page.
To explore the post further or for any queries you may have, please contact:
Sadie Reed, Head of Trial Management
Tel: +44 (0)113 343 6441; Email: firstname.lastname@example.org