Job summary
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.
Main duties of the job
- 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
About us
Imperial College London is the UKs only university focussed entirely on science, engineering, medicine and business and we are consistently rated in the top 10 universities in the world.
You will find our main London campus in South Kensington, with our hospital campuses located nearby in West and North London. We also have Silwood Park in Berkshire and state-of-the-art facilities in development at our major new campus in White City.
We work in a multidisciplinary and diverse community for education, research, translation and commercialisation, harnessing science and innovation to tackle the big global challenges our complex world faces.
Its our mission to achieve enduring excellence in all that we do for the benefit of society and we are looking for the most talented people to help us get there.
Job description
Job responsibilities
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 AdministratorsOversee 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 legislationStrong IT literacy (MS Office), including use of pivot tables in Excel.Demonstrated success in managing clinical trials budgets.Strong management and motivational skillsEffective communication, negotiation, presentation, and interpersonal skillsCritical attention to detail and high levels of accuracyExcellent organizational and time management skillsWillingness to travel within the UK and internationally.Willingness to work flexibly outside of office hours on occasion.Previous experience/exposure to clinical practiceWillingness 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 ([email protected]).
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.
Person Specification
Qualifications
Essential
- Bachelor's degree or equivalent
Desirable
- Postgraduate qualification or equivalent, which includes clinical trials
- methodology
Experience
Essential
- - Proven clinical trial/project management experience gained in multi-centre, phase II and/or phase III, randomised trials including CTIMPs
- - Demonstrated success in the management of clinical trials budgets
- - Evidence of strong IT literacy (MS Office) including use of Pivot tables in excel
- - Extensive knowledge of the current EU Clinical Trials Directive, UK Clinical Trials regulations, Principles of GCP, Data Protection Act (GDPR) and Research Governance Framework legislation and proven ability to apply these to the coordination of clinical trials
Desirable
- - Experience of managing publicly funded applications
- - Evidence of using an electronic CRF
- - Evidence of preparing regulatory and ethics submissions, writing/amending protocols, PIS, CRFs and other relevant trial management documentation
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Employer details
Employer name
Imperial College London
Address
Du Cane Road, Hammersmith, London
London
W12 0NN