Senior Clinical Trial Manager/Progamme Manager

The primary purpose of the post is to provide administrative and secretarial support to Professor Sudhin Thayyil and to the Senior Clinical trials manager in managing a large portfolio of national and international clinical trials and research, and in developing grant applications. The Clinical Trial administrator will work with the other research staff managing these trials and provide appropriate administrative support. The post holder will also work closely with the finance teams in preparing financial reports, grant costings and submitting annual reports to the funding bodies.

The post holder will lead a large multi-country clinical research program for developing new methods for preventing and treating hypoxic ischemic encephalopathy. Our current programs include HELIX trial (Hypothermia for Encephalopathy in low and middle-income countries) trial (largest hypothermia trial in the world and selected in the top 50 clinical trials in neonatal medicine); PREVENT (Prevention of Epilepsy by reducing Neonatal Encephalopathy) study involving 60,000 women recruited from several hospitals in India (NIHR RIGHT program), COMET (Cooling in Mild Encephalopathy versus Targeted normothermia) trial involving 430 babies with mild encephalopathy from 40 NHS hospitals (NIHR HTA); EMBRACE trial (Erythropoietin Monotherapy in Neonatal Encephalopathy in Low- and Middle-income countries) in India and Bangladesh involving 500 babies from several hospitals in India and Bangladesh (Thrasher foundation); and EDEN (Extended Darbepoetin in Neonatal Encephalopathy) involving 100 babies with neonatal encephalopathy in the UK (NIHR).

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

You will be responsible for the trial management of a portfolio of trials within the Centre from conception to completion including trial coordination, data management and administrative activities to ensure the smooth running and progress of the trial.  You will build and maintain partnerships and collaborations and be the first point of contact for internal and external stakeholders, providing expert advice, and helping to identify, evaluate and rectify problems.  You will need to work closely with stakeholders such as CI, statisticians, national and international academic collaborators, vendors, and funding partners to ensure good communication between all parties

You will ensure that the appropriate ethical and regulatory requirements are obtained and ensure ongoing compliance and governance are in adherence and ensure the safe conduct of the trial with adherence to necessary pharmacovigilance e.g. reporting of adverse events, expedited safety reporting and submission of Annual Safety reports.

You will lead on aspects of the portfolio management including forming and hosting Public and Patient Involvement groups and research capacity building.  Plan, develop and implement comprehensive procedures for timely and clear reporting of trial status including progress and recruitment rates.  You will also act as the main point of contact for all issues relating to the creation and working of the electronic data capture system including the randomisation service. 

You will lead on the development and delivery of the Monitoring Plan and other essential trial documentation and 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.

You will be responsible in reviewing and managing the trial grant funding, including reviewing expenditure against budget and ensuring that expenditures adhere to the terms of all relevant funding contracts, in collaboration with the Departmental Administrator and Imperial Administrators.  You will oversee payments made to investigators and partner organisations and assist with the development of payment/tracking systems to ensure accountability

Essential requirements

• Proven clinical trial/project management experience gained in multi-centre, phase II and/or phase III, randomised trials including CTIMPs
• 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 trialsEvidence of strong IT literacy (MS Office)
• Demonstrated success in the management of clinical trials budgets
• Skills & Abilities
• Strong management and motivational skills
• Evidence of ability to work independently as well as part of a team
• Evidence of effective communication, negotiation, presentation and inter-personal skills
• Evidence of ability to work with critical attention to detail and high levels of accuracy
• Proven excellent organisational and time management skills to effectively handle conflicting priorities and ensure tight deadlines are met
• Other
• Willingness to travel within the UK and internationally
• Willingness to work flexibly outside of office hours on occasion e.g. for travelling to and from sites
• Previous experience/exposure to clinical practice
• Willingness to undergo any training deemed to be necessary for the full execution of trial duties

Further information

This is full-time and fixed-term for 5 years in the first instance. This post will be based within the Centre for Perinatal Neuroscience at Hammersmith Hospital with overall line management provided by Professor Sudhin Thayyil. We are passionate about gender equity and strongly encourage women with young children to apply.

A DBS check will be required for this role.

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.

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