Our Organisation
Clinical trial management is about running meaningful trials, in a compliant way, to deliver high quality datasets. It’s a career which offers many opportunities for enthusiastic and motivated individuals; it’s interesting, dynamic, challenging and there’s something new to learn every day.
Our Trial Management teams are central to this, and are supported by a number of specialist teams or individuals each making a vital contribution to the setting-up, running and delivery of results for a clinical trial.
Trial Management Teams: Supporting Successful Clinical Trials
Trial Management Teams play a vital role in delivering clinical trials that make a real difference to patients. They work closely with researchers, NHS staff, funders, and external partners to ensure trials run smoothly, stay on schedule, and produce reliable results. Their work supports progress in cancer research and helps improve patient care.
Clinical trials are complex, and challenges can arise at any stage. Trial Management Teams keep studies on track by planning ahead, solving problems, and making sure everyone involved is well informed. Team members must be organised, adaptable, and confident communicators, as they work with many people and organisations throughout the life of a trial.
Trial Managers
Trial Managers are responsible for the overall coordination and delivery of clinical trials. They have strong knowledge of clinical trial processes, Good Clinical Practice (GCP), and UK ethical and regulatory requirements. Trial Managers often lead a small team and work closely with the Chief Investigator to plan and deliver the trial.
Their role includes helping to develop the trial protocol, securing approvals, and setting up systems to support trial activities. Trial Managers oversee timelines, budgets, and participating hospitals, and ensure that trial data are collected accurately and consistently. They also work with external partners such as laboratories, drug suppliers, and funders.
An important responsibility is maintaining the Trial Master File, which contains essential trial documents and is regularly reviewed by the Medicines and Healthcare products Regulatory Agency (MHRA). Trial Managers must be flexible and well organised to respond to unexpected issues as trials progress.
Clinical Trial Administrators
Clinical Trial Administrators (CTAs) support Trial Managers with the day-to-day running of trials. Many CTAs have experience in healthcare, laboratories, or data-focused roles. They help manage trial supplies, support data collection, and maintain regular contact with participating hospitals. CTAs also carry out routine checks to ensure trials are run in line with required standards.
Clinical Trial Support Officers
Clinical Trial Support Officers (CTSOs) provide administrative support across several trials. Their main role is checking data submitted by hospitals to ensure it is complete and accurate. CTSOs work with sites to resolve queries so data can be used confidently for analysis. This role is ideal for those new to clinical trials and offers a strong introduction to trial management.
Specialist Support for Trial Management Teams
Clinical trials depend on strong teamwork. Alongside Trial Management Teams, a range of specialist roles within the Clinical Trials Unit (CTU) provide essential support at every stage of a trial. From early planning through to delivery and analysis, these specialists help ensure trials run safely, efficiently, and to a high standard.
Each role works closely with Trial Managers, investigators, and trial sites, making an important contribution to the successful delivery of clinical research.
Senior Trial Managers
OCTO has two Senior Trial Managers who each oversee a portfolio of clinical trials. They are highly experienced professionals who work with investigators to shape trial design and agree how studies will be delivered. During trial set-up, they help calculate trial costs and support funding and grant applications. Senior Trial Managers also contribute to decisions about which trials the unit should take on and provide line management and professional support to Trial Managers, helping maintain consistent standards across the unit.
Pharmacovigilance Manager
Patient safety is a top priority in all clinical trials. The Pharmacovigilance (PV) Manager ensures that safety systems are in place and followed across all trials. They review reported safety events to assess whether they were expected and whether they may be related to the trial treatment. The PV Manager also ensures that events meeting regulatory requirements are reported to the appropriate authorities within required timelines. This work is particularly complex in oncology trials, where patients often receive multiple treatments and have other health conditions.
Data Managers
Data Managers design and maintain the systems used to collect trial data, most often electronic case report forms (eCRFs). They work closely with Trial Management Teams to ensure data are collected accurately, securely, and in line with required standards. Data Managers also produce reports and data extracts that support trial monitoring and decision-making.
Statisticians and Programmers
Statisticians work with the Chief Investigator and Trial Manager to develop the trial design and statistical approach, write the Statistical Analysis Plan, and lead the analysis of trial results. Statistical support for OCTO trials is provided by OCTRU.
Programmers support the technical systems used to capture and manage trial data. They design, test, and maintain systems that meet regulatory requirements and, where needed, develop solutions to combine data from multiple sources. The programming team is based within OCTRU.