We are looking for a successful and dynamic Clinical Project Manager to assist with running three multi-centre clinical trials, led by in the . The trials have a focus on hypoxic ischemic encephalopathy, a birth related brain injury which impacts around three million babies every year, predominantly in low and middle-income countries. The trials are:

PREVENT (Prevention of Epilepsy by reducing Neonatal Encephalopathy) study involving 60,000 women from several hospitals in India (NIHR RIGHT program). This is the world’s largest study on babies with birth related brain injury. 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). COMET (Cooling in Mild Encephalopathy) trial involving 430 babies with mild encephalopathy from 40 NHS hospitals funded by NIHR HTA program.

As the Clinical Trial Manager for the COMET study, you will oversee all aspects for the study. This will include travelling to various NHS sites to enable their induction, working closely with the trial Research Nurses and clinical staff for engaging potential participants, reporting to the funder, and developing trial and patient facing documents.. You will work with the EMBRACE project manager to ensure coordination of regulatory submissions for the group, as well as assisting on running the PREVENT study.

You should be a motivated individual with significant experience in clinical trials of investigational medicinal products, enabling you to provide efficient regulatory / administrative support.You should be educated to Degree level, or have extensive experience within the field of Clinical Project Management.You should have experience of managing, directing and supporting multiple staff in a research, healthcare or clinical research setting, including engaging and directing complex groups of stakeholders and suppliers.You should have in depth working knowledge of the current 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 clinical trials.
The opportunity to continue your career at a world-leading institutionSector-leading salary and remuneration package (including 38 days off a year)