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Generic job description for a clinical trials manager

 

Contents

Description

The post holder will have the leading role in planning, coordinating and completing the project. They will have excellent communication and presentation skills, together with the ability to organise and motivate others. 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 project.

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

Responsibilities

  • The overall efficient day-to-day management of the trial.
  • Recruitment, retention, training, appraisal and supervision of trial team members.
  • Establishment of procedures to ensure adherence to trial protocols and administrative requirements.
  • Ensuring the timely recruitment of trial participants with secure randomisation processes and subsequent efficient and effective data management.
  • Monitoring trial progress to ensure compliance with and adherence to the project plan and to identify, evaluate and rectify problems.
  • Management of the trial budget(s) and maintenance of the accounts.
  • Act as the point of contact for all external and internal agencies.
  • Co-ordinate the preparation and publication of data, reports and information, ensuring that they meet legislative, contractual and ethical requirements.
  • Understand the requirements of the various controlling bodies, agencies and frameworks, guiding the project in conforming to those requirements and co-ordinating any necessary audit processes.
  • Liaison with the Trials Steering Committee and Data Monitoring and Ethics Committee with a particular view on compliance with Research Governance, Good Clinical Practice, Data Protection and Ethical Requirements.
  • Provision of regular and ad hoc information, both written and verbal, to all the trial participants and sponsors, to include reports, updates, guidance, preformed commitments and possibly a newsletter.
  • Work with the Chief Investigator to ensure that the trial is meeting its targets, is producing meaningful output and to predict and plan any changes that warrant requests to changes in protocol, funding or time.
  • Ensure the inclusion of consumer group representatives at the appropriate levels and times.
  • Planning and supporting the meetings and work of the various groups and bodies associated with the trial.
  • Creation and maintenance of all trial files, including the trial master file, and oversight of site files.
  • Assurance that personal and confidential information is restricted to those entitled to know.