Clinical Trials Manager
Clinical Trials Manager
Department of Surgery and Cancer/Division of Surgery/ Faculty of Medicine
Charing Cross Hospital and St Marys Hospital, Medical School Building, with travel to other Imperial Campuses
Professional Services, Level 4
Professor Anthony Gordon – Section of Anaesthetics, Pain Medicine and Intensive Care / Professor Steve Brett – BLING III Trial UK Chief Investigator / Operations Manager
Key Working Relationships (internal):
Chief Investigator; Division of Surgery/ Clinical Trials Research / ITU Sepsis Research Group, Joint Research Compliance Office (JRCO), Colleagues in Division, Department, Imperial College Healthcare NHS Trust (ICHNT), Imperial Clinical Trial Unit (ICTU)
Key Working Relationships (external):
Investigators and teams at external sites/hospitals, Collaborators at The George Institute, Sydney, Australia
Full time, fixed term for 48 months in the first instance
The post will be primarily based within the Department of Surgery and Cancer, Section of Anaesthetics, Pain Medicine and Intensive Care. The post will be closely linked with The Imperial Clinical Trials Unit (ICTU). ICTU is a research unit working across both Imperial College London and Imperial College Healthcare NHS Trust delivering world-class clinical trials.
Activities will encompass all aspects of all stages of clinical trials from generation to delivery of the trial and require expertise in trial methodology and all aspects of delivery in key disease areas. ICTU and the Sepsis Research Group work closely with the Joint Research Compliance Office of Imperial College London to ensure that the regulatory, legal and quality control aspects of trials are met.
BLING III Trial
The trial is being sponsored by The George Institute (TGI), Sydney, Australia, and the UK sites will be managed by Imperial College London (UK Chief Investigator Professor Steve Brett).
We will be conducting an international multicentre randomised, controlled trial (RCT) to determine whether continuous infusion of a beta-lactam antibiotic (piperacillin-tazobactam or meropenem) results in decreased all-cause Day 90 mortality compared with intermittent beta-lactam antibiotic infusion in critically ill patients with sepsis.
This study will provide vital evidence to answer the clinically important question of whether there is a difference in patient-centred outcomes in critically ill patients with sepsis administered beta-lactam antibiotics by continuous infusion versus intermittent infusion. If a 3.5% absolute reduction in hospital mortality is observed, then this intervention has the potential to save over 750 lives each year in Australia and New Zealand alone (based on severe sepsis incidence data). This research will provide pivotal evidence on the optimal method of delivery of commonly used beta-lactam antibiotics via a phase III RCT of global relevance.
Participants commenced on one of two beta-lactam antibiotics (piperacillin-tazobactam or meropenem) will be randomised to receive the beta-lactam antibiotic via either continuous infusion or intermittent infusion over 30 minutes for the treatment course for up to 14 days after randomisation while in the ICU
The purpose of the post:
The post holder will act as the Clinical Trial Manager for the BLING III Trial described above. They will undertake the day to day management of the trial. He / she will be responsible for all aspects of trial coordination, together with data management, to ensure that the trial is conducted to the highest scientific and regulatory standards, as well as delivered to time and within budget constraints. The postholder will be expected to travel between the Imperial Hospital Campuses – St Mary’s Hospital, Charing Cross Hospital and Hammersmith Hospital as well as travel to national sites who are recruiting patients into the trial.
- Be responsible for all coordination and administrative activities, including some data management, to ensure the efficient running of the trial.
- Establish and maintain good communication between all key stakeholders e.g. Australian and UK 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.
- Obtain / assist with applications for initial approvals and ensure on-going adherence to the requirements of the regulatory bodies i.e. NHS Research & Development, and Research Ethics Committee (REC); and submit amendments as appropriate.
- Maintain the Trial Master File.
- Contribute to the development of all study documentation, under the guidance of other experienced Trial Managers / 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.
- 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 visits according to the monitoring plan and in line with the study risk assessment.
- Write monitoring visit reports and ensure action points are followed up with sites in a timely manner
- Manage processes for monitoring and making payments to sites for recruitment if appropriate.
- Provide cross-study cover for other members of the Sepsis Research Group as required.
- Assist in preparation of presentations and publications.
- Together with the study statistician and other team members, to develop and maintain the study database.
- Manage timely and efficient procedures for collection, computer entry and verification of all patient data, raising queries for missing or incomplete data as appropriate.
- Ensure quality and completeness of data using appropriate quality control measures.
- Assist in the production of written reports as required by the Management Team and CI.
- Submit accrual figures to relevant groups.
- Monitor trial grant funds, reviewing expenditure against budget and ensuring adherence to terms of all relevant contracts in collaboration with the Finance Manager and Imperial Administrators.
- Oversee payments made to investigators and assist with development of payment / tracking systems to ensure accountability.
- Major contractual arrangements (including the development of new contracts) with outside organisations as required.
- Be familiar with the relevant clinical literature and keep up-to-date with literature relating to clinical research / trial methodology.
- Perform any other duties which may be required that are consistent with the nature and grade of the post as required by the CI.
- Undergo any training deemed to be necessary for the full execution of trial duties.
- Assist with the preparation and conduct of any future GCP inspection
- Ensure familiarity with and adherence to all relevant ICTU and TGI SOPs.
- Observe and comply with all College policies and regulations, including the key policies and procedures on Confidentiality, Conflict of interest, Data protection, Equal opportunities, Financial Regulations, Health and Safety, Imperial Expectations (for new leaders, managers and supervisors), Information Technology, Private Engagements and Register of Interests and Smoking.
Candidates/post holders will be expected to demonstrate the following
- First degree or equivalent in a biomedical/scientific or allied field.
Experience & Knowledge
- Proven clinical trial coordination experience.
- Working knowledge of the EU Clinical Trials Directive, UK Clinical Trials regulations, Principles of GCP, Data Protection Act and Research Governance Framework legislation and proven ability to apply these to the coordination of a clinical trial.
- Evidence of preparing regulatory and ethics submissions and amending protocols, patient information sheets, electronic databases and other relevant trial management documentation.
- Evidence of strong IT literacy (MS Office and use of electronic Case Report Forms).
- Experience of data entry and data management processes.
- Postgraduate qualification or equivalent which includes clinical trials methodology or translational research.
- Evidence of basic understanding of the Human Tissue Act.
- Evidence of working in Intensive Care research or a related field
Skills & Abilities
- Evidence of effective communication, presentation and inter-personal skills.
- Proven ability to organise and prioritise workload to meet deadlines.
- Proven ability to work independently as well as part of a team.
- Ability to work accurately and methodically with a meticulous attention to detail.
- Creative approach to problem solving.
- Willingness to travel within the UK.
- Flexible approach to working hours
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.
Imperial College is committed to equality of opportunity and to eliminating discrimination. All employees are expected to follow the 7 Imperial Expectations detailed below:
- Champion a positive approach to change and opportunity
- Encourage inclusive participation and eliminate discrimination
- Communicate regularly and effectively within and across teams
- Consider the thoughts and expectations of others
- Deliver positive outcomes
- Develop and grow skills and expertise
- Work in a planned and managed way
They must also undertake specific training and assume responsibility for safety relevant to specific roles, as set out on the College Website Health and Safety Structure and Responsibilities page.
The College is a proud signatory to the San-Francisco Declaration on Research Assessment (DORA), which means that in hiring and promotion decisions, we evaluate applicants on the quality of their work, not the journal impact factor where it is published. For more information, see https://www.imperial.ac.uk/research-and-innovation/about-imperial-research/research-evaluation/
The College believes that the use of animals in research is vital to improve human and animal health and welfare. Animals may only be used in research programmes where their use is shown to be necessary for developing new treatments and making medical advances. Imperial is committed to ensuring that, in cases where this research is deemed essential, all animals in the College’s care are treated with full respect, and that all staff involved with this work show due consideration at every level.
Committed to equality and valuing diversity, 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.