We are seeking
to appoint an experienced Clinical Trial Manager to support DEN-HOST, a large randomised adaptive phase 3 trial evaluating therapeutics for patients hospitalised with moderate or severe dengue. This post will be based at Big Data Institute, Li Ka Shing Centre for Health and Information Discovery, Old Road Campus, Headington, Oxford, OX3 7LF. The trial aims to identify safe and affordable treatments that prevent disease progression in high-risk patients and improve outcomes for those with established severe disease, thereby reducing the burden on health systems in dengue-endemic regions. DEN-HOST will initially test three host-directed therapeutics. The trial aims to recruit up to 8,000 patients across 25 sites in Peru, Colombia, Brazil, Bangladesh, Indonesia, Malaysia, Cambodia, Thailand, Nepal and Vietnam, over a 5-year period. It will build on established networks including RECOVERY, ISARIC, PREPARE and OUCRU. You will play a key role in trial set-up, including the establishment of Regional Coordinating Centres (RCCs), and setting up of governance and operational frameworks, as well as leading ongoing trial delivery and oversight once recruitment begins. This will involve serving as the primary operational contact for RCC leads, monitoring enrolment and trial conduct, coordinating protocol amendments, ensuring governance and regulatory compliance, and overseeing trial documentation. You will also provide leadership within the Central Coordinating Office, including line-management of a Clinical Trials Assistant, and help ensure efficient and collaborative working practices across all partners. It is essential that you have a degree in a biomedical or associated subject, or other relevant qualification or proven experience in clinical research and substantial experience in international clinical trial set-up and delivery. Strong knowledge of ethics applications, Sponsor approvals, Clinical Trial Agreements, due diligence, and risk and governance frameworks are also essential, alongside experience of managing multi-partner budgets and reporting. You will also need excellent communication skills, the ability to work collaboratively across multi-disciplinary, multi-country teams, and prior experience in line-management.