This part time (0.5FTE) post is available immediately on a 3 year fixed term basis.
We have an exciting opportunity for a Clinical Trial Manager to join the Exeter Clinical Trials unit in collaboration with the MRC-CMM.
You will play a pivotal role in supporting the cASPerCF study (Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection). This is a prestigious European funded study which will be performed within the conect4children network (https://conect4children.org). The cASPerCF study intends to provide a prospective validation and clinical evaluation of safety and efficacy of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection.
The cASPerCF Trial Manager will coordinate and be responsible for the day-to-day activities of a trial and therefore holds a pivotal position. This person will support the Chief Investigator to coordinate the planning phases of the clinical protocol, especially for the medical writing activity and the finalization of core documentation of the study (such as Clinical Protocol, ICF, Investigator Brochure, CRF, site training materials, etc.). In addition, this person will be responsible and ensure that all necessary data is collected in a timely manner by working closely with the CVBF to ensure that the database design will allow for the necessary prompts and reports to facilitate timely data collection. This person will need to have an in-depth knowledge of the trial’s data collection and management systems.
The MRC Centre for Medical Mycology, supports the cASPerCF Study Team and Chief Investigator, along with other trial staff in Europe to assist the Chief Investigator to fulfil the operational and trial duties required of running a complex multicentre Clinical Trial of an Investigational Medical Product (CTIMP)
Exeter Clinical Trials Unit (ExeCTU) is a UKCRC registered University of Exeter supported facility and works in collaboration with researchers and clinicians in the design and delivery of high quality and efficient controlled trials and other well-designed studies addressing important health questions. The post holder will be supported by an experienced team of trialists within the ExeCTU.
The Medical Research Council Centre for Medical Mycology (MRC CMM) is one of the most ambitious strategic investments in UK medical mycology. The MRC CMM is a world-leading research centre that is helping to tackle the major global threats to human health caused by fungal diseases. In fact, fungal infections now kill more people worldwide than malaria and similar numbers to tuberculosis. The Centre brings together researchers from the fields of medicine and living systems, and the biological, chemical, physical and mathematical sciences to increase our understanding of fungal pathogens and cognate immune defences, and to identify new ways to diagnose, prevent and treat fungal diseases. A major activity of the MRC CMM is to increase UK capacity in fundamental and clinical research in medical mycology through research and training programmes for medical and biosciences students and early career researchers. The Centre has established strategic interactions with other national and international groups is promoting public engagement and understanding of our science.
You can view the Job Description and Person Specification document here.
This role may be subject to additional background screening.