We are seeking a Global Study Manager II to support our global labs. This position will by hybrid with 3 days onsite and 2 days from home. The Study Manager is responsible for the successful delivery of the study management activities related to companion diagnostic studies in their specific area of the world. Coordinates, plans, organizes and oversees, in his regional location, the completion of administrative and technical tasks during the companion diagnostic study life time in collaboration with the Principal Investigator, the regional laboratory testing site and the various internal departments involved in the deliverables of the study. The Study Manager ensures the three ways communication with the regional Diagnostic Client in their specific area of the word, the Global Study Manager appointed to the Pharma Sponsor and the regional laboratory operations testing site. Acts as consultant/Technical Expert in providing recommendations/advice to all parties, a-day-to-day project management oversight by managing, planning and coordinating all projects related as well as maintaining study documentation in accordance with customer expectations and in compliance with regulatory requirements. Will be accountable to ensure global consistency of the Diagnostic program across the different laboratory principal investigator testing sites where the diagnostic trial is conducted. Will coordinate the regulatory aspects with the appropriate operational groups including Medical Affair and Quality Assurance departments.
Experience Required:
3 years of clinical laboratory experience or customer service experience, preferable in pharmaceutical industry. Experience with multidisciplinary lab background is a plus.
BS degree in Biology, Chemistry or other Life Science; or Medical Technologist degree.
Professional certification (ASCP,PMP or other) in area(s) expertise
Geneva site: qualification by the Foederation Analyticorum Medicilanium Helveticorum (FAMH) or by the Foederation Medicorum Helveticoruma (FMH)
Labcorp is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
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