Global Study Manager I

We are seeking a Global Study Manager I to be responsible for the successful delivery of the study management activities related to diagnostic studies in their specific area of the world. This position will be located onsite at our facility in Torrance, CA (19750  S. Vermont Ave). This is a hybrid position with 3 days onsite and 2 days remote.

The Study Manager I coordinates, plans, organizes and oversees, in her regional location, the completion of administrative and technical tasks during the Dx 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. Ensures the three ways communication with the regional Diagnostic Client in their specific area of the word, the PM 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.

This position must deliver outstanding customer satisfaction and performances.

Duties will include the following:

• Act as regional internal liaison to ensure proper and smooth communication between  the Diagnostic Sponsor, the PM Global Study Manager, the Principal Investigators/Scientists, the laboratory operation and the various internal departments involved in the study ( Quality Assurance, Commercial Development, Global Laboratory Services Support, Specimen Storage, Data Management, Client Services, Information Technology) develop solutions, resolve issues and approve internal database loading/design plan

• Act as regional external liaison with assigned Diagnostic Client representatives (eg. Diagnostic CRA, Site Monitors, Study Managers) the PM Global Study Manager and the internal clients to ensure an outstanding – timely communication

• Accountable of the proper and timely delivery of all the regional study related aspects and deliverables from win study notice  to the closure of the study by working in close collaboration with the PM Global Study Manager and the Diagnostic Global Study Managers

• Review the Diagnostic component of study Statement of Work to ensure local feasibility and make appropriate recommendations to the Study Design Lead in collaboration with the PM Global Study Manager  and the DDS Global Study Manager

• Act as a remote regional liaison between Global Study Manager and the various internal departments involved in the study.

• Participate in Covance CLS development through continuous process improvement, quality and productivity

• Demonstrate through appropriate self-organization the ability to manage high administrative load

• Able to act efficiently in an environment with dynamic timelines and priorities

• Demonstrate strong interpersonal and communication skills that will build strong internal and external relationships to ensure deliverables are on time and within budget

• Upon management assignment, the Study Manager I may be assigned with Global Study Management duties.

• Ensure global consistency of the Dx program across the different testing sites location, including  lab operation processes harmonization,  

• Implement, monitor, set up local performance metrics and take corrective actions when needed,

• Pre win consultation support with the Dx client and the commercial development department.

• Manage and monitor the Diagnostic Sponsor budget in collaboration with PM Global study Manager

• 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

• 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

• 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   

• 5 years of clinical laboratory experience or customer service experience, preferable in pharmaceutical industry.  Experience working with multidisciplinary labs is a plus. 

Education Required:

• BS degree in Biology, Chemistry or other Life Science; or Medical Technology degree.

Preferred:

• 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.

For more information about how we collect and store your personal data, please see our Privacy Statement.