Clinical Trial Manager

Location: Hammersmith Campus

Job Summary

Imperial College London is a world-class research institution dedicated to advancing knowledge and improving lives through groundbreaking research and education. We are currently seeking a Clinical Trial Manager to join our team and contribute to our exceptional research programs.

We have an exciting opportunity to join the Centre for Perinatal Neuroscience within the Department of Brain Sciences, Imperial College London.

Around three million babies die or sustain life changing disabilities from hypoxic ischemic encephalopathy (birth related brain injury) every year. Over 95% of the disease burden occur in low and middle-income countries. We lead one of the largest clinical research programs in hypoxic ischemic encephalopathy in the world and have an established track record of conducting impactful research.

The post holder will manage the COMET (Cooling in Mild Encephalopathy) trial involving 430 babies with mild encephalopathy from 40 NHS hospitals. The trial is funded by NIHR HTA program. You will be responsible for all aspects of the trial including developing various trial and patient facing documents, obtaining regulatory approvals, finance management, liaising with investigators at the participating sites, IDMC and trial steering committees, and reporting to the funding bodies under the supervision of the Centre director.

You will have outstanding leadership and communication skills and ability to manage a multidisciplinary of around 30 research nurses, data entry clerks, project managers and fellows based primarily in the UK, India, Sri Lanka, and Bangladesh, and will be highly experienced in all aspects of clinical trials management. You will be responsible for liaising with investigators at the participating sites, IDMC and trial steering committees, reporting to the funding bodies, and in supporting the centre director in the preparation of grant applications.

You will also be responsible for training and managing trial staff and implementing/adapting established Imperial College London systems and processes to ensure the trial is developed and conducted to the highest scientific and regulatory standards. Other aspects of portfolio management include forming and hosting Public and Patient Involvement groups and research capacity building.

Duties and responsibilities

Trial Management

• Manage the COMET Trial from conception to completion including trial coordination, data management and administrative activities to ensure the smooth running and progress of the trial.
• Travel to national and international sites for site initiation/set up visits and monitoring.
• Plan, develop and implement comprehensive procedures for timely and clear reporting of trial status including progress and recruitment rates.
• Oversee the creation and maintenance of all study files, including the trial master file (TMF) and have oversight of site files ensuring all essential documents are filed correctly and kept up to date.
• Oversee the study monitors work in accordance with ICH guidelines on clinical trial monitoring, local regulatory requirements and the study monitoring plan, and perform Source Data Verification (SDV) of study data at participating sites to check original source documents against what has been entered into the study database

Finance Management

• Review and manage trial grant funding, reviewing expenditure against budget and ensuring adherence to terms of all relevant contracts, in collaboration with the Departmental Administrator and Imperial Administrators
• Oversee payments made to investigators and partner organisations and assist with development of payment / tracking systems to ensure accountability including raising purchase orders and setting up suppliers.

Essential requirements

• Proven clinical trial/project management experience in multi-centre, phase II and/or phase III, randomized trials including CTIMPs.
• Extensive knowledge of EU Clinical Trials Directive, UK Clinical Trials regulations, Principles of GCP, Data Protection Act (GDPR), and Research Governance Framework legislation
• Strong IT literacy (MS Office), including use of pivot tables in Excel.
• Demonstrated success in managing clinical trials budgets.
• Strong management and motivational skills
• Effective communication, negotiation, presentation, and interpersonal skills
• Critical attention to detail and high levels of accuracy
• Excellent organizational and time management skills
• Willingness to travel within the UK and internationally.
• Willingness to work flexibly outside of office hours on occasion.
• Previous experience/exposure to clinical practice
• Willingness to undergo necessary training for trial duties.

Further Information

This post is full time, fixed term until April 2029 based at Hammersmith Campus.

As this post is exempt from the Rehabilitation of Offenders Act 1974, a satisfactory Disclosure and Barring Service (DBS) check, at the appropriate level, will be required for the successful candidate.

Should you require any further details/information please contact Prof. Sudhin Thayyil (s.thayyil@imperial.ac.uk)

Please note that job descriptions cannot be exhaustive, and the post-holder may be required to undertake other duties, which are broadly in line with the above key responsibilities.

For any technical enquiries, please contact support.jobs@imperial.ac.uk

Hybrid working may be considered for this role.  Staff working in roles that are suitable for hybrid working will normally be expected to work 60% of their time onsite. The opportunity for hybrid working will be discussed at interview.

More information is available on the following web page: Work Location Framework | Administration and support services | Imperial College London

Imperial College is committed to equality of opportunity, to eliminating discrimination and to creating an inclusive working environment. We are an Athena SWAN Silver award winner, a Stonewall Diversity Champion, a Disability Confident Employer and work in partnership with GIRES to promote respect for trans people.