Senior Trial Manager for ROSSINI Platform Trial - Birmingham Clinical Trials Unit - 104932 - Grade 7

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

• Design and prepare new clinical trial proposals, including costings, grant applications, protocol writing, and designing case report forms and databases.
• 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.
• Prepare interim publications and ensure timely final research publications.
• 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.
• Manage selected trials, organize meetings, reports, and oversee trial setup, site monitoring, and compliance with legislation.
• Ensure data accuracy and completeness, working with statisticians to validate data.
• Supervise and support junior staff, including work allocation, training, and performance monitoring.
• Mentor and develop team members.
• Obtain regulatory and ethical approvals, report adverse events, and ensure SOP compliance.
• Prepare progress reports for regulatory bodies, ethics committees, and collaborators.
• Serve as a point of contact for site queries and provide cover for Trial Managers.
• Promote the trial portfolio through newsletters, posters, and presentations at scientific meetings.
• Develop SOPs for trial conduct and oversee database design and testing.
• Set up clinical sites, ensure protocol and GCP compliance, and maintain audit trails.
• Monitor trial progress, address recruitment and compliance issues, and conduct quality assurance visits.
• Interpret statistical data.
• Participate in trial management groups and support collaborative activities.
• Plan budgets and negotiate with suppliers.
• Organize meetings and supervise courses and students.
• Contribute to setting and maintaining policies, standards, and frameworks within the CTU.
• Promote equality and diversity, fostering an inclusive culture.
• 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.

We value diversity and are committed to equality, inclusion, and sustainability.