Job Detail

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.