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Demonstrated understanding of research and ability to develop methodologies in clinical analytics and other innovative statistical/mathematical approaches Strong facilitation skills, including the abi...
The FBH Clinical Manager is an inspirational and innovative clinical leader and member of the FBH Site Leadership Team fostering and working collaboratively to forward the values and goals of the Fami...
Defines and develops strategies to work with cross functional departments to build ‘inspection readiness’ and consistently identify and mitigate risk across processes...
Provides oversight towards CRO and other vendors to ensure deliverables are on time and within the agreed cost and quality.
Oversees successful implementation of Gilead (GS), Collaborative (CO), Investigator Sponsored Research (ISR) program, expanded access programs, and compassionate use programs...
Works closely with clinical study management teams , and external Contract Research Organizations to provide expert clinical compliance information, manage identified issues, and support/drive continu...
Along with the Director, Regional Clinical Trial Operations, establishes a strategic vision and long-range plan for the RCTO team.
Manage external CMO to ensure quality and timely supply of drug substance to support all pipeline products. Develop CMC plan in alignment with overall program strategy, and the requirements of pre-cli...
· Write, edit and facilitate the review of study reports, study protocols, investigator’s brochures, clinical data summaries, and other medical/regulatory documents, including the development...
Develop or review externally developed clinical study protocols, informed consent forms, clinical study reports and other clinical documents. Plan and participate in site selection, site initiation vi...