Clinical Trial Manager

? Main purpose of the job

An experienced, enthusiastic, committed and professional individual is sought for this post, which is based in Holborn, London. The primary role of the post holder is to set up and support a high-quality clinical trial at the CCTU. The post holder will be responsible to a CCTU Clinical Project Manager.

Duties and responsibilities

• To establish and maintain effective management systems for the trial
• To act as the central Trials Unit contact for the Trial
• To work closely with the Chief Investigator, trial and IT staff to ensure the successful management of the Trial.
• Secure all necessary approvals for the trial and participating sites according to the UK regulations including UK Research Governance Framework
• Coordinate the design, printing and distribution of trial documentation
• Develop trial specific documentation that is compliant with the CCTU Policies and Standard Operating Procedures (SOPs) and ensure this is implemented and kept up to date.
• Ensure sites have appropriate training and maintain necessary records.
• Work within budget constraints in liaison with the Project Manager.
• Ensure that good communication is maintained between the CCTU and recruiting centre staff
• Provide updates on the progress of the trial at regular Trial Management Group meetings, to the Independent Data Monitoring and Trial Steering Committees and to the funder as required.
• Monitor the trial sites to assess compliance with the protocol and regulatory requirements.
• Prepare under the guidance of the Clinical Project Manager, the trial specifications for the Database.
• Undertake Risk Assessment of the trial and, with the Clinical Project Manager, propose appropriate mitigations.
• Minute trial related meetings.
• Supervise the data collected and enter data if required.
• Supervise the data cleaning and validation, including querying and chasing missing data in a timely manner.
• Monitor trial recruitment, providing support and motivation to recruiting staff as required.
• Ensure the timely submission and processing of data and documents from sites to the CTU including safety events.
• Prepare and submit the necessary reports to appropriate regulatory, ethical and other parties (such as submission of safety reports to the Ethics Committee).
• Represent the trial at conferences, meetings and internal unit meetings as appropriate.
• Keep the relevant literature searches up to date.
• Participate in UCL and the CCTU training and development initiatives.
• Carry out any other comparable tasks as required including being prepared to assist those working on other studies/trials as directed by the Head of Clinical Trial Operations.