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Generic job description for a clinical trials manager


Published: 10 June 2019

Version: 2.0 - September 2022

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The post holder will have a leading role in planning, coordinating and completing the study to time and to target, as part of a multidisciplinary team.

They will have specialist knowledge of applicable regulations, nationally and internationally as appropriate, and be able to provide regulatory and/or governance advice where required. They will demonstrate flair, enthusiasm, innovation and leadership when faced with challenges and will provide strategic, tactical and operational management skills in the planning and execution of the study. They will have excellent communication and presentation skills, together with the ability to organise and motivate others. 

Previous experience in the management and co-ordination of clinical studies is desirable but not essential; however, appropriate academic and/or vocational qualifications are necessary. 


The postholder will be responsible for the overall management and oversight of the study, in compliance with the study protocol and international standards of Good Clinical Practice (GCP). They will work closely with the Chief Investigator(s) and wider multidisciplinary team.  

Key responsibilities will include but are not limited to: 

  • Understanding the requirements of the various ethical and regulatory bodies, agencies and frameworks, guiding the study in conforming to those requirements and co-ordinating any necessary audit processes.
  • Preparing study materials and establishing procedures to ensure adherence to study protocols and administrative requirements. 
  • Leading on the creation and maintenance of all study files, including the study master file, and oversight of site files.
  • Leading with the recruitment, training, appraisal, retention and supervision of study team members.
  • Coordinating applications, and subsequent amendments as applicable, to ethical and regulatory bodies.
  • Performing site visits to facilitate study set up and initiation, regular monitoring visits duringpatient recruitment, and close out visits on study completion. 
  • Leading study oversight groups (such as study Management Group, study Steering Committee, Data Monitoring Committee) by organising and facilitating meetings, providing reports and documentation to committees and following upon agreed actions.
  • Regularly liaising with study sites and other members of the core team (data managers, statisticians, epidemiologists) to ensure follow-up visits data are kept up-to-date, accurately completed and that loss of patient data is kept to a minimum.
  • Ensuring the timely recruitment of study participants with secure randomisation processes and subsequent efficient and effective data management. 
  • Ensuring that all study adverse events are appropriately investigated by the study staff and accurately reported to the investigatorsand regulatory bodies as required.
  • Monitoring study progress to ensure compliance with and adherence to the study plan and to identify, evaluate and rectify problems.
  • Supporting investigators in the collection and monitoring of study data and to liaise with collaborators, study doctors and the data manager to ensure that follow-up information is kept up-to-date, accurately completed and that loss of patient data is kept to a minimum. 
  • Preparing research progress and monitoring reports for, organise and minute regular meetings with the appropriate Steering Committee and Data Monitoring Committees, as applicable, ensuring compliance with Research Governance, Good Clinical Practice, Data Protection and ethical requirements, as applicable.
  • Provision of regular and ad-hoc information, both written and verbal, to all the study participants and sponsors, to include reports, updates, guidance, preformed commitments and possibly a newsletter, or similar, as appropriate.
  • Co-ordinating the preparation and publication of data, reports and information, ensuring compliance with applicable contractual and ethical requirements.
  • Ensuring the inclusion of patients and public involvement and engagement group representatives at the appropriate levels and times.
  • Acting as the first point of contact for all external and internal agencies.
  • Any other ad-hoc tasks as requested by the Chief investigator(s).

This job description was developed as a template by the UK Trial Managers’ Network (UKTMN). The document should be tailored in accordance with the specific needs of the project and/or department. Trial managers should be supported in their individual professional development, with time allocated within their job description to undertake professional development activities, including training course attendance. UKTMN endorses the principles outlined within the Vitae Researcher Concordat, proposing researchers engage in a minimum of 10 days professional development pro rata per year.

The UK Trial Managers’ Network is a network of trial management professionals within the UK. They provide many resources for trial management staff, including support in study management and professional development. More information can be found at