In this position the Clinical Trial Manager will play a key role in supporting the design, managing the implementation and conduct of the next stage of state-of-the-art clinical utility prospective multi center trial(s) and registries across a number of continents that may help change the standard of care and improve patient outcomes in transplantation. The candidate will provide direction and operational leadership of the clinical research studies to ensure delivery on time, within budget, and of high-quality in compliance with ICH GCP, Internal SOPs and all other applicable regulations.
The Clinical Trial Manager should be a critical thinker and capable of problem solving and aligning the priorities with study outcomes and timelines as well as be proactive and unafraid to get their hands dirty. A good candidate should demonstrate clinical development experience of the operational aspects of all stages of clinical studies preferably working in and/or monitoring or leading affiliate teams, working with vendors and/or CROs, study supply management and planning operational activities to achieve database lock. A knowledge of molecular diagnostics and regulation associated with this space across multiple continents is an essential component of this role.