Job DescriptionThis is an excellent opportunity for an experienced Clinical Study Manager who has experience with early phase studies to join a pioneering Biotech based in Worthing, Sussex who are about to embark on a new paediatric trial. This is a newly created role and offers remote working.
• To set-up and manage allergy immunotherapy interventional clinical trials phases I-III in one or multiple countries, coordinating internal stakeholders and selecting/overseeing Contract Research Organisations (CROs), other service providers and investigators to delivery studies of high standard and quality on time and on budget.
• To champion for good interdepartmental/inter-functional cooperation while leading, co-leading, or assisting the leadership of a clinical trial, taking responsibility for the guidance, training and direction of junior staff in achieving study targets
• Relevant life science degree and higher degree with experience matching the level of the role; in clinical trial management or clinical research
• Knowledge and understanding of Good Clinical practice and applicable regulatory environment
• Experience in leadership of clinical trial management, including management of CROs, multiple vendors and consultants
• Experience with EDC systems
• Several years as CSM in addition to experience as a CRA
• Experience of phases I-III, with a focus on phase I
• Experience of oncology, immunology or allergy trials would be an asset, but not essential.