The Lead Clinical Trial Operations Manager (Lead CTOM) is responsible for all operational aspects of clinical trial oversight including the delivery of every study on time within budget and scope in compliance with GCP’s, SOPs and standards.
The Lead CTOM is responsible for the coordination of internal/external resources and third parties/vendors for the flawless execution of the study.
The Lead CTOM is involved in the scientific conduct of the study and acts with a critical thinking and problem solving mindset.
This role is also responsible for the preparation of study related materials, relationship management between clinical sites and vendors, and identification of project risks and contingency planning. You must be comfortable working independently, managing interactions with and between clinical monitors, biostatistics, medical writing, safety and other key stakeholders. The Lead CTOM ensures trial(s) are managed to the highest quality to strive for safety and effectiveness of Sanofi products.