We are looking for a successful and dynamic Clinical Trial Monitor/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 Monitor/Manager, you would be working primarily on the PREVENT and EMBRACE studies. You will assist with the management and monitoring of the trials and helping with data analysis and publication preparation. This will include building partnerships with oversea stakeholders, ensuring ethical approvals are maintained, and leading on development and delivery of the monitoring plan. You will work closely with the COMET trial’s Clinical Trial Manager and the EMBRACE study’s Clinical Project Manager, to ensure coordinated submission of regulatory and financial reporting.
You should be a motivated individual with experience in working on 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 working on clinical trials.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)
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