This position works out of our Alameda, CA location in the Lingo Division. Working on Lingo, you will help build a next-generation technology that enables individuals to make decisions about how to improve energy, lose weight or enhance athletic performance. The Clinical Affairs Manager will manage teams within the Medical Affairs Sub-Function. Focus is on policy and strategy implementation and control rather than development. Typically handles short-term operational/tactical responsibilities. As the Manager of the Clinical Affairs Sub-Function, oversees the strategy implementation and operations for overseeing the direction, planning, execution, clinical trials/research and the data collection activities. Contributes to implementation of clinical protocols and facilitates completion of final reports. Recruits clinical investigators and negotiates study design and costs. Responsible for directing human clinical trials, for company products under development. Participates in adverse event reporting and safety responsibilities monitoring. Coordinates and provides reporting information for reports submitted to the regulatory agencies. Monitors adherence to protocols and determines study completion. Coordinates and oversees investigator initiations and group studies. May act as consultant/liaison with other corporations when working under licensing agreements. Required Qualifications: Bachelor's degree, Minimum 8 years of relevant experience. Preferred Qualifications: Master’s or PhD degree in science or a related field. Experience with quality management system GAP analysis and audit preparation. Strong clinical operations background. Previously work in roles that require understanding of digital consumer behavior. Software life cycle experience. Experience with CAPA.
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