TCTU Portfolio Clinical Trial Manager (SOPHIST) - UOD1986
| Posting date: | 20 August 2025 |
|---|---|
| Salary: | £41,671 to £45,413 per year |
| Hours: | Full time |
| Closing date: | 27 August 2025 |
| Location: | Dundee, Dundee, DD2 1SG |
| Company: | University of Dundee |
| Job type: | Contract |
| Job reference: | 5641_1755684302 |
Summary
Portfolio Trial Manager (SOPHIST),
TCTU Grade 7 (£37,174 to £45,413)
Duration - Part time, 0.8fte, fixed term until 31/08/2026. Part time and job share considered
1. Job Purpose:
Tayside Clinical Trials Unit (TCTU) has full registration with the UKCRC. TCTU's role is to provide support and services to investigators, delivering high quality trial design from idea conception through protocol development and onto publication. In addition, TCTU aims to improve the success and quality of clinical trials. Visit https://www.dundee.ac.uk/tctu/ for more information. TCTU is an operational subunit of TASC. To find out more about TASC please visit https://www.dundee.ac.uk/tasc.
We are looking for a motivated individual, experienced in the management of clinical trials to join TCTU. You will be a member of an existing, experienced team, working closely with TCTU Senior Clinical Trial Managers and other TCTU staff across a portfolio of new and established trials. In particular, you will provide dedicated support to the SOPHIST trial, "Sotagliflozin in Patients with Heart Failure Symptoms and Type 1 Diabetes" a UK wide drug trial being managed by TCTU. As a Portfolio Trial Manager, you will work with CIs and academic trial teams to provide support and advice on the approval process, trial management and delivery of drug trials and complex intervention studies across a broad spectrum of disease indications and populations. As TCTU supports local, national and international studies, some travel will be required both national and international depending on relevant travel restrictions.
The post is 0.8 full time equivalent, fixed term until 31/08/2026 but may be extended subject to grant income. Part time, job share and secondment options will be considered.
2. Main Responsibilities
Responsibility
Work with the TCTU Senior Management Team to implement common working practices and SOPs with regard to trial management activity within Tayside and to ensure trials managed by the TCTU adhere to sponsor, TASC and TCTU procedures and national regulatory requirements.
Acting under the direction of the TCTU Senior Clinical Trial Managers, to provide support and to carry out specific duties with respect to the day-to-day trial management activities of TCTU portfolio studies: including leading or guiding the approvals process and managing amendments; maintaining study documentation, centrally and at sites; ensuring the timely recruitment of trial participants with secure randomisation processes and subsequent efficient and effective data management and analysis; ensuring that appropriate procedures for pharmacovigilance are in place; preparation of content and update of trial web pages; monitoring the trial progress to ensure compliance with and adherence to the project plan and to identify, evaluate and rectify problems; liaising with the study data management team to ensure systems are to appropriate regulatory standards.
Provide advice to CIs and trial teams on recruitment, retention, training, communication and delivery of clinical trials including changes to trial documentation. To assist CIs and trial teams to develop communication strategies and systems for sharing information locally and with the collaborating sites. Implement procedures to ensure adherence to trial protocols and administrative requirements. Ensure each trial, where necessary, establishes a Trial Management Group, Trial Steering Committee and Data Monitoring and Ethics Committee, with a particular focus on compliance with Research Governance, Good Clinical Practice, Data Protection and Ethical Requirements. Regularly attend internal meetings/committees and be proactive in suggesting solutions to trial operational problems/issues as they arise. Provide regular and ad hoc reports on clinical trial activity as required. TCTU Portfolio TM v9 05-08-2025 SOPHIST 3 Responsibility Delivery of training on all aspects of clinical trial management and co-ordination to a range of staff as required. Input to the strategic development of TCTU, such as review of processes and procedures, attendance at conferences and introduction of best practice within the unit. Keep abreast of new legislation and ensure that processes and standards for clinical trials are adhered to in order to meet existing statutory / regulatory requirements. Other TCTU or TASC duties as reasonably requested by the TCTU Senior Management Team.
3. Planning and Organising
* Prioritise own daily workload in accordance with the framework of the trial programme.
* Be an active participant in regular planning and technical project meetings.
* Support the prioritisation of workload as agreed with the TCTU Senior Clinical Trials Managers and TCTU Assistant Directors.
4. Problem Solving
* Ability to analyse, interpret and implement trial management solutions to meet the requirements of the trial.
* Resolve any trial management issues in a prompt and efficient manner.
5. Decision Making
* Manage day to day issues as they arise and decide when it is necessary to refer outstanding issues to TCTU Senior Clinical Trial Managers or CI.
* Ensure that trial protocols and working practices for clinical trials are communicated to investigators in order to meet existing statutory / regulatory requirements.
6. Key Contacts/Relationships * Strong working relationships are essential within the TCTU team in order to share knowledge and ensure the smooth running of our trials. The post holder will be expected to liaise with and attend technical meetings with TCTU staff, trialists, trial managers and other trial stakeholders (TASC, ethics, trial committees etc.).
* The post holder may be expected to organise, attend and/or contribute to relevant meetings relating to the study, and to write and distribute minutes of meetings.. *
Where appropriate the post holder will participate in the writing up, publication and dissemination of findings related to the research.