Position Details
Birmingham Clinical Trials Unit
Location: University of Birmingham, Edgbaston, Birmingham UK
Full-time starting salary is normally in the range £36,130 to £45,413, with potential progression to £48,149 once in post.
Grade: 7
Full Time, Fixed Term contract up to December 2029
Closing date: 8th June 2025
Role Summary
Responsible for managing a portfolio of trials related to a clinical specialty and the staff involved, as well as actively coordinating trials. Contribute to the design, conduct, analysis, publication, and presentation of clinical trials research.
Main Duties
1. Design and prepare new clinical trial proposals, including costings, grant applications, protocol writing, and designing case report forms and databases.
2. Stay updated with research literature and developments in the relevant clinical specialty. Maintain bibliographies, review literature critically, and contribute ideas for innovative trials and methodologies.
3. Prepare interim publications and ensure timely final research publications.
4. Keep abreast of changes in trial methodology, regulations, and legislation. Develop strategies for implementation and disseminate best practices internally and externally. Contribute to quality assurance through SOPs.
5. Manage selected trials, organize meetings, reports, and oversee trial setup, site monitoring, and compliance with legislation.
6. Ensure data accuracy and completeness, working with statisticians to validate data.
7. Supervise and support junior staff, including work allocation, training, and performance monitoring. Mentor and develop team members.
8. Obtain regulatory and ethical approvals, report adverse events, and ensure SOP compliance.
9. Prepare progress reports for regulatory bodies, ethics committees, and collaborators.
10. Serve as a point of contact for site queries and provide cover for Trial Managers.
11. Promote the trial portfolio through newsletters, posters, and presentations at scientific meetings.
12. Develop SOPs for trial conduct and oversee database design and testing.
13. Set up clinical sites, ensure protocol and GCP compliance, and maintain audit trails.
14. Monitor trial progress, address recruitment and compliance issues, and conduct quality assurance visits.
15. Interpret statistical data.
16. Participate in trial management groups and support collaborative activities.
17. Plan budgets and negotiate with suppliers.
18. Organize meetings and supervise courses and students.
19. Contribute to setting and maintaining policies, standards, and frameworks within the CTU.
20. Promote equality and diversity, fostering an inclusive culture.
21. Support research delivery in accordance with GCP, legislation, and policies to ensure participant safety and data integrity.
Required Knowledge, Skills, Qualifications, and Experience
* A higher degree (PhD or MSc) in a relevant biomedical science or related field, with clinical trials experience, or extensive trial management experience with proven senior capability.
* Deep understanding of clinical research, trial management, regulatory requirements, and application skills.
* Experience in regulatory and ethics submissions, grant writing, protocol development, and documentation.
* Strong project management and supervisory skills.
* Excellent administrative and communication skills.
* Advanced computing skills, including database design and management (MS Access preferred).
* Ability to work independently, problem-solve, and pay close attention to detail.
* Experience in preparing publications and grant applications.
* Willingness and ability to travel nationally and internationally as required.
* Knowledge of equality legislation and practices to promote fairness and inclusivity.
Further details are available here.
For informal enquiries, contact Manjinder Kaur at m.kaur@bham.ac.uk.
Learn about our staff values and behaviours here.
We value diversity and are committed to equality, inclusion, and sustainability. Find out more on our website.
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