The Trial Manager (TM) will lead on all aspects of trial management, through all stages; acting as the key point of contact with stakeholders to oversee trial conduct, from set-up to close down. The TM ensures trials are delivered within the proposed timeframe and in accordance with Good Clinical Practice (GCP), the Declaration of Helsinki, applicable legislation. The TM will manage one or more trials and line manage operational staff. This post is based in the Bristol Trials Centre (BTC), a UKCRC-registered clinical trials unit.
Please be advised, interview for this post will take place in January.
What will you be doing?
- Ensure the efficient day-to-day management, closure, archiving & dissemination of the trial in accordance with study protocols & standard operating procedures, monitoring for errors in the trial and issues with participant recruitment/retention rates, escalating or taking action to resolve.
- Prepare applications for initial approvals and ensure on-going adherence to the requirements of the regulatory bodies, facilitating contractual arrangements and amendments by liaising between the relevant parties
- Develop and maintain training resources for trial processes and study documentation, adhering to all relevant ethical, legal, data protection and governance requirements and that trial staff and other stakeholders are trained in their use.
- Ensure data collection is conducted within agreed deadlines, liaising with the Database team to develop the databases & undertaking regular checks on data quality, taking appropriate steps to correct data issues and amend processes to improve data quality
- Monitor progress against targets including financial expenditure, verifying the costs payable to external organisations & providing reports/updates to relevant committees and stakeholders, which may include sensitive information about performance and change.
- Line manage trial staff, delegating workload as appropriate, dealing with staff issues that arise and participating in the recruitment & selection of new staff
- Coordinate start and finish groups, contribute to the wider BTC initiatives and promote the BTC values
You should apply if you have:
- Considerable experience in trial management of multi-centre randomised controlled trials from start-up to closure.
- A good understanding of the principles of trial design with an excellent understanding of the regulatory & governance research environment in the UK
- Proven organisational skills & attention to detail, able to organise own time effectively, prioritising to deliver workload to deadlines and to agreed standards.
- Proven analytical & problem-solving capability, able to diagnose problems, identify key issues, evaluate alternative courses of action, produce an acceptable solution and take effective decisions
- Able to motivate & lead a team of researchers and a willingness to pass on own skills and knowledge.
Contract type: Open-ended with fixed funding for 12 months from the start of the contract
Work pattern: Full-time/ 1 FTE/Hybrid working model of remote and in-office working
For informal queries please contact: Jodi Taylor, firstname.lastname@example.org
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The University of Bristol aims to be a place where everyone feels able to be themselves and do their best in an inclusive working environment where all colleagues can thrive and reach their full potential. We want to attract, develop, and retain individuals with different experiences, backgrounds and perspectives – particularly people of colour, LGBT+ and disabled people - because diversity of people and ideas remains integral to our excellence as a global civic institution.