Senior Trial Manager - Birmingham Clinical Trials Unit - 101417 - Grade 7

Position Details

Salary range: £36,636 to £46,049, with potential progression to £48,822. Grade: 7.

Our Offer

We offer a generous benefits package, including 40 days annual paid holiday, one paid day per year for volunteering, occupational sick pay and a pension scheme.

Three high‑quality subsidised day nurseries are also available.

Role Summary

Responsible for managing a portfolio of trials within a clinical specialty and coordinating the teams that run them.

Contribute to the design, conduct, analysis, publication and presentation of clinical trials research.

Main Duties

• Lead the design and preparation of new clinical trial research proposals, including costings, grant applications, protocol writing, and database design.
• Keep up to date with current research literature and develop innovative trial methodologies, maintaining relevant bibliographies.
• Prepare interim publications such as meeting abstracts and drive completion of final research publications.
• Advise on changes in trial methodology, regulatory and legislative requirements, and help implement them at team and national levels.
• Personally manage selected trials: lead meetings, oversight of trial set‑up and monitoring of clinical sites, ensuring compliance with legislation.
• Ensure trial data completeness and accuracy, working closely with the statistical team for data validation.
• Provide day‑to‑day supervision, motivation, work allocation and support for junior staff, including mentoring and training.
• Obtain regulatory and ethical approvals for individual trials and supervise safe conduct, including adverse event reporting.
• Prepare trial progress reports for regulatory authorities, ethics committees, steering bodies, funders and collaborators.
• Serve as point of contact for site queries, providing support for Trial Managers.
• Promote the trial portfolio through newsletters, posters and presentations at local, national and international meetings.
• Prepare standard operating procedures for each trial to ensure compliance with current legislation.
• Oversee the design, coding and testing of research databases.
• Set up clinical sites and ensure trial staff understand Good Clinical Practice and maintain audit trails.
• Monitor site progress, address recruitment, protocol adherence and data quality issues, conducting Q/A monitoring visits as required.
• Interpret statistical data.
• Participate in trial management groups, steering committees, Data Monitoring Committees and collaborative groups, organising and administering trials.
• Plan expenditure against trial budgets and negotiate with suppliers.
• Deliver relevant lectures and supervise students as required.
• Contribute to setting and communicating trial unit policy and quality standards to staff.
• Model equality, diversity and inclusivity, promoting an inclusive working culture.
• Ensure compliance with Good Clinical Practice, Declaration of Helsinki, Medicines for Human Use Clinical Trials Regulations, General Data Protection Regulation, Data Protection Act 2018, Human Tissue Act, Research Governance Framework, Caldicott principles and university policies protecting research subjects.
• Required Knowledge, Skills, Qualifications, Experience
• Higher degree (Ph D or MSc) in a relevant biomedical science or similar, with experience in clinical trials research, or a graduate with strong Trial Manager experience and a proven senior‑role record; proven success in securing research funding from a recognised body may also suffice.
• In‑depth understanding of clinical research and trial management methodology, including regulatory requirements.
• Experience preparing ethics and regulatory submissions, grant applications, protocol and consent documents, case report forms, reports and other trial documentation.
• Proven project management and supervisory skills.
• Excellent administrative, clerical and office management abilities.
• Strong communication, negotiation, presentation and interpersonal skills.
• Advanced computing skills, especially word processing, email, and experience with relational databases (MS Access preferred).
• Ability to work independently and solve problems.
• High standards of accuracy and detail orientation.
• Experience preparing publications and submitting grant applications.
• Willingness to travel nationally and occasionally internationally.
• Knowledge of the Equality Act 2010 protected characteristics and ability to ensure equal treatment in practice.
• Application Process

Use of AI in applications: We encourage genuine self‑expression; applications heavily reliant on AI tools risk being overlooked.

• Contact
• For informal enquiries, contact William Mc Kinnon by email: w. mckinnon@bham. ac. uk

We are committed to diversity and inclusion, proudly holding Athena SWAN, Race Equality Charter and Disability Confident accreditations.

Sustained efforts are made to create a fairer university for all.

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