Clinical Trial Operations Lead

Cpl Group; Greater London; On-site; GBP 52,000 - 65,000; Full time

Job summary

Cpl Group, based in Holborn, London, seeks an experienced trials professional to set up and support a high-quality clinical trial at the CCTU. The post holder reports to the Clinical Project Manager and will drive trial operations across site management, regulatory compliance and data handling.

Responsibilities include establishing and maintaining management systems, coordinating trial documentation, training sites, monitoring recruitment, and delivering progress updates to Trial Management

Responsibilities

• Establish and maintain effective management systems for the trial.
• Act as the central Trials Unit contact for the Trial.
• Collaborate with the Chief Investigator, trial and IT staff for trial management.
• Secure approvals for the trial and sites per UK regulations including UK Research Governance Framework.
• Coordinate design, printing and distribution of trial documentation.
• Develop trial documents compliant with CCTU SOPs and keep them updated.
• Ensure sites have training and maintain records.
• Work within budget constraints with the Project Manager.
• Maintain good communication between CCTU and recruiting centre staff.
• Provide updates on trial progress at Management Group meetings and to the funder.
• Monitor sites for protocol and regulatory compliance.
• Prepare trial specifications for the Database under the Clinical Project Manager.
• Undertake risk assessment and propose mitigations with the CPM.
• Minute trial-related meetings.
• Supervise data collection and entry as required.
• Supervise data cleaning and validation, including chasing missing data.
• Monitor trial recruitment and motivate staff.
• Submit data/documents to the CTU and report to regulators.
• Represent the trial at conferences and internal meetings.
• Keep literature searches up to date.
• Participate in UCL and CCTU training and development initiatives.
• Carry out other tasks as directed by the Head of Clinical Trial Operations.
• Work on other studies/trials as directed.

Job description

Cpl Group, based in Holborn, London, seeks an experienced trials professional to set up and support a high-quality clinical trial at the CCTU. The post holder reports to the Clinical Project Manager and will drive trial operations across site management, regulatory compliance and data handling.

Responsibilities include establishing and maintaining management systems, coordinating trial documentation, training sites, monitoring recruitment, and delivering progress updates to Trial Management