Research Project Manager
Research Project Manager
University of Dundee
Dundee, Ireland
The role holder's primary focus will be the BRIDGE study, a multicentre pan-European study aiming to recruit 1000 patients with respiratory disease into an observational study in which patients will donate multiple biological samples for next generation sequencing, "omics" analysis and detailed phenotyping leading to the development of personalised medicine.
The role holder will also provide support across other studies within the respiratory team. Working closely with the Chief Investigator (CI), local and site research teams as well as scientists and data management team to ensure the implementation of all aspects of the study, including research governance, maintaining ethical and regulatory approval, communication with and training of staff at collaborating sites, promoting the study to research networks and patient groups, maintaining trial documentation and reporting.
As the portfolio consists of multi-centre studies travel to sites across the UK and Europe will be expected.
Based in Ninewells Hospital, one of Europe's largest teaching hospitals, the School of Medicine provides outstanding medical education and training supported by world class research facilities.
Your priorities will include:
- Working with the CI, the study team, the Research Nurses, third party stake holders, including patient groups and external laboratories. The post holder will be responsible for co-ordinating the clinical research portfolio on behalf of the CI and will be the primary contact for study collaborators, clinicians, research nurses and study participants. The studies must be run to the expected UK regulatory standards and in line with TASC policies and procedures;
- Work with the CI and sites to introduce and maintain common working practices and SOPs and to identify training requirements of local and participating site trial personnel. This includes protocol development, management of ethical and regulatory approval and the establishment of governance issues;
- Ensure accurate collection and recording of data and maintenance of study documentation across local and national study teams. Create and populate local Trial Master Files and issue Site Files to participating centres. Collate site agreements and evidence of local approvals;
- Ensure the timely recruitment of study participants. Monitor the study progress to ensure compliance with and adherence to the project plan and to identify and rectify problems as they arise;
- Work with investigators, ethics committee(s), regulatory authorities, and local governance office to manage any changes to study documentation.
Who we're looking for:
- A minimum of an MSc in nursing, biomedical, life sciences or other relevant discipline;
- At least 3 years' experience working in clinical research;
- Good knowledge of current scientific, regulatory and ethical frameworks defining trial management activity;
- Practical knowledge of academic trial management;
- The ability to work effectively within a multi-disciplinary research team.
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