Senior Trial Manager - Birmingham Clinical Trials Unit - Grade 7
Overview
Location: University of Birmingham, Edgbaston, Birmingham UK
Full time
Full time starting salary normally in the range £36,130 to £45,413 with potential progression to £48,149 in post
Grade: 7
Fixed term contract up to October 2026
Closing date: 9 November 2025
This role is also open as an internal secondment opportunity which would need to be agreed by your current line manager. UK and international travel may be required for this role.
Role Summary
Responsible for managing a portfolio of trials associated with a clinical specialty and the staff working on those trials in addition to actively coordinating trials. Contribute to the design, conduct, analysis, publication and presentation of clinical trials research.
Main Duties
* Take a fundamental role in the design and preparation of new clinical trial research proposals and contribute to the Clinical Trial Unit’s research activity and profile. This includes preparation of costings and grant applications; writing and editing the protocol, and design of case report forms and databases used to collect research data.
* Keep up to date with current research literature and developments in the clinical speciality relevant to the portfolio of trials; maintain bibliographies by regular literature searches and critical review. Bring ideas for innovative trials to the attention of the clinical lead. Write literature reviews and develop innovative approaches to improving trial methodology.
* Prepare interim publications (e.g. meeting abstracts) and play a pivotal role in the preparation and timely completion of final research publications.
* Keep up to date with changes in trial methodology, regulatory issues and new legislation. Help develop strategies for their implementation at team level and national level if appropriate. Disseminate new skills, knowledge and best practice internally and externally to study sites as appropriate. Contribute to the quality assurance programme by writing/approving/implementing Standard Operating Procedures for the trials unit.
* Personally manage selected trials, lead in preparing and organising meetings, reports and other activities of high importance or complexity requiring specialist knowledge. This includes setting up new trials, negotiating with external bodies, overseeing site setup and monitoring, and ensuring trials are run in accordance with current legislation.
* Take primary responsibility for ensuring that trial data are complete and accurate; work closely with the statistical team to validate the data set.
* Manage junior staff with day-to-day supervision, motivation and support, including work allocation, cover rotas, problem solving, staff development and performance monitoring. Advise on appointments and training of junior trial management staff. Mentor and coach other team members as necessary.
* Obtain appropriate regulatory and ethical approvals for individual trials. Ensure Standard Operating Procedures for safe conduct are followed (e.g., reporting adverse events to regulatory authorities and the Data Monitoring Committee).
* Prepare trial progress reports as required by regulatory authorities, ethics committees, Trial Steering and Data Monitoring Committees, funding bodies and external collaborators.
* Provide a first point of contact for day-to-day queries from study sites regarding protocol compliance and provide cover for Trial Managers.
* Promote the research portfolio by preparing newsletters, posters and presenting at local, national and occasional international scientific meetings.
* Prepare Standard Operating Procedures for the running of individual clinical trials to ensure compliance with current legislation.
* Initiate and oversee the design, coding and testing of research databases; set up clinical sites and ensure participating staff understand and comply with the trial protocol and Good Clinical Practice, maintaining audit trails in line with legislation.
* Monitor progress of each centre and take action to ensure good recruitment, protocol adherence and data quality. Address practical difficulties at sites affecting recruitment, protocol adherence or patient safety; conduct quality assurance visits as required.
* Interpret statistical data and act as a member of trial management groups, coordinating activities of the Trial Management Group, Steering Committee, Data Monitoring Committee and larger collaborative groups.
* Plan expenditure against trial budgets and negotiate with suppliers. Organise national meetings including agenda preparation and sponsorship where needed.
* Lecture on relevant courses and supervise students as required.
* Contribute to setting, maintaining and communicating Clinical Trial Unit policy, quality standards and trial management frameworks to junior staff.
* Promote equality and diversity and foster an inclusive working culture.
* Support the delivery of clinical research in accordance with Good Clinical Practice, the Declaration of Helsinki, applicable legislation (including Medicines for Human Use Clinical Trials Regulations, GDPR, Data Protection Act 2018, Human Tissue Act), Research Governance Framework, Caldicott principles and applicable policies to protect research subjects and study quality.
Required Knowledge, Skills, Qualifications, Experience
* A higher degree (PhD or MSc) in a relevant biomedical science or related subject with experience in clinical trials research, or a graduate with strong trial management experience and potential for a senior role.
* In-depth understanding of clinical research and trial management methodology, regulatory requirements, and ability to apply these to coordinating trials.
* Experience preparing regulatory and ethics submissions; grant applications; writing/amending protocols; patient information sheets; case report forms; reports and other trial management documentation.
* Proven project management and supervisory skills.
* Excellent administrative, clerical and office management skills.
* Effective communication, negotiation, presentation and interpersonal skills.
* Excellent computing skills including advanced word processing and email; experience with designing, maintaining and querying complex relational databases (MS Access preferred).
* Ability to work on own initiative and solve problems; high attention to detail and accuracy.
* Experience preparing publications and submitting grant applications.
* Ability to travel nationally and internationally on occasion.
* Knowledge of the Equality Act 2010 protected characteristics and how to ensure fair treatment in day-to-day activity.
Further particulars can be found here. Informal enquiries to Manjinder Kaur, email: m.kaur@bham.ac.uk. View our staff values and behaviours here. We are committed to equality, diversity and inclusion and to sustainability as part of our strategy.
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