Job Overview : Are you an experienced Project Manager looking for your next challenge? Do you want to work for a global organisation with un-parrelled career development opportunities?
Do you want to work for a company that helps build a healthier and safer world?
Covance is a global, world-leading Life Sciences Contract Research Organisation that provides dedicated and fully comprehensive laboratory testing and drug development services to the pharmaceutical industry.
We strive to make a difference to people’s everyday lives by bringing essential medicines to the market. At Covance we are looking to recruit Senior Study Manager to join our expanding team.
Job responsibilities include :
As a key member of the project management team, you will be responsible for the successful delivery of the study management activities related to companion diagnostic studies in their specific area :
Day-to-day local study related activities- including but not limited to (90%) Prepare, organize and host CRA visits as needed.
Participate into and prepare Client Audit related to Diagnostic studies Prepare, coordinate set up and monitors study timelines and ensure proper coordination with the regional laboratory testing site, the CRA and all internal departments involved Submit regulatory authority applications Manage and lead external and internal meetings Track monthly Diagnostic services billable activities Report Adverse Events as needed to the global diagnostic Study Manager and Principal Investigator / Scientist Report protocol deviations as needed to the global diagnostic Study Manager and Principal Investigator / Scientist Ensures that all customer expectations are documented and acted upon in compliance with regulatory requirements Serve as back up to Regional Study Coordinators and Study Managers Global Study Management responsibilities : Ensure laboratory processes harmonization across CLS sites location.
Ensure Diagnostic protocols and program consistency across CLS sites location Ensure proper escalation of internal misalignment and inconsistencies and propose corrective and preventive actions Manage, monitor Diagnostic Client Budgets in coordination with the PM global study manager
Regulatory / Study Documentation duties (10% )
Maintain all necessary study documentation, including but not limited to : study binders, material receipt forms, and material balance forms.
Maintain all necessary study documentation, : study binders, material receipt forms, and material balance forms Participate in team meetings and take minutes Organize and Archiving study documentation and correspondence as requested by the client Filing and collating trial documentation and reports Perform physical inventory of study materials as needed Track monthly Diagnostic services billable activities Report Adverse Events as needed to the global diagnostic Study Manager and Principal Investigator / Scientist Report protocol deviations as needed to the global diagnostic Study Manager and Principal Investigator / Scientist
Education / Qualifications : BS degree in Biology, Chemistry or other Life Science; or Medical Technologist degree. Professional certification (ASCP,PMP or other) in area(s) expertise, prefered for Geneva site : qualification by the Foederation Analyticorum Medicilanium Helveticorum (FAMH) or by the Foederation Medicorum Helveticoruma (FMH), prefered Experience : Minimum Required : 3 years of clinical laboratory experience or customer service experience, preferable in pharmaceutical industry or CRO Experience with multidisciplinary laboratory background is a plus.
2020-06-02 12 : 43 : 32