This is a great opportunity offering a minimum 12 months As a Clinical Trial Manager based in London.

Our client delivers world class clinical trials of all phases and designs. The Unit also collaborates with members of the designated Academic Health Science Network other national clinical and scientific key opinion leaders, other CTUs and with Industry.

The Unit leads primarily on the design, conduct and analysis of national and international multi-centre trials and staff, with specialist disease and methodological knowledge, have input at all stages of the trial lifecycle; thus ensuring all activities are conducted according to the principles of ICH GCP and in compliance with the appropriate regulatory and ethical requirements. The Unit also manages a small early phase portfolio with an emphasis on the design and analysis aspects of these studies. Current therapeutic areas of expertise include Cancer, Cardiovascular, Emergency Medicine and Critical Care, Infectious Diseases and Surgery.

Here's an idea of what you will be doing:

You should be an experienced Trial Manager with experience within a Cardiovascular randomised multi-centre controlled investigational medicinal product (IMP) clinical trial.

You will already be the lead in co-ordinating and completing projects and will oversee all aspects of trial management and monitoring, including implementing established systems to ensure the trial is developed and conducted to the highest scientific and regulatory standards.

You will also be expected to travel on occasion between the other sites , to national sites participating in the trial and potentially to US sites.

You should recognise yourself here:

Trial Management

• Be responsible for all coordination and administrative activities, including trial monitoring, IMP management and data management, to ensure the efficient running of the allocated trial.
• Establish and maintain good communication between all key stakeholders e.g. study team, JRCO, funder(s), pharmaceutical collaborators, academic collaborators and staff at participating sites.
• Implement the principles of the International Conference on Harmonisation Good Clinical Practice (ICH-GCP) guidelines for clinical trials and ensure that all study personnel work according to them.
• Prepare and submit applications for initial approvals and ensure on-going adherence to the requirements of the regulatory bodies i.e. NHS Research & Development, Medicines and Healthcare products Regulatory Agency (MHRA) and Research Ethics Committee (REC); and submit amendments as appropriate.
• Prepare trial progress reports and/or routine reports to funder, research ethics committee, MHRA, NIHR portfolio, trial committees and Sponsor.
• Maintain the Trial Master File.
• Contribute to the development of all study documentation, under the guidance of the Operations Manager / Chief Investigator (CI) / Trial Management Group (TMG) including Study Protocol, Patient Information Sheet, Consent Form, GP letter and any other study materials.
• Co-develop standard operating procedures (SOPs) for the initiation and coordination of the study.
• Set up new sites and conduct initiation visits as required.
• Liaise with pharmacies and ensure timely supply of investigational drug to sites.
• Ensure necessary pharmacovigilance by reporting of adverse events, expedited SAE/SAR/SUSAR reporting and submission of Annual Safety Reports and DSURs.
• Convene meetings of the TMG, Steering Committee and Data Monitoring Committee and provide associated documentation.
• Plan and conduct site monitoring and closeout visits according to the monitoring plan and in line with the study risk assessment.
• Manage the closeout for the trial including: conducting remote and on-site closeout visits, data cleaning, preparation of end of study reports for REC, MHRA, Sponsor and funder
• Write monitoring visit reports and ensure action points are followed up with sites in a timely manner
• Manage processes for tracking and making payments to sites for recruitment / sample collection if appropriate.
• Provide cross-study cover for other members of the Unit as required.
• Assist in preparation of presentations and publications.
• Act as the main point of contact for the trial.Â
• Ensure that all trial documentation is effectively archived as required.Â
• Monitor trial finances, reviewing expenditure against budgets and ensuring adherence to terms of all relevant contracts, in collaboration with the Operations Manager, ICTU Departmental Manager and Section Manager.

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