Global CDx Study Manager 1

If you are looking for a company where you can personally advance healthcare and have influence in peoples' lives with your bold ideas and unique points of view, consider working at Labcorp as a Global CDx Study Manager supporting our Companion Diagnostics (CDx) team.

In this role, you will be responsible for the successful delivery of the study management activities related to diagnostic studies. You will coordinate, plan, organize, and oversee work to include the completion of administrative and technical tasks during the Diagnostic (Dx) study lifetime in collaboration with the Principal Investigator, the regional laboratory testing site, and the various internal departments involved in the deliverables of the study.

The Global CDx Study Manager will ensure effective collaboration between the Diagnostic Client, the Global Study Manager appointed to the Pharma Sponsor, and the regional laboratory operations testing site. The Global CDx Study Manager 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 will be lab/office based in our Torrance, CA location with work from home flexibility twice a week.

In more details, you will...

General duties:

• Function as ambassador on behalf of the Diagnostic client across Labcorp departments; exemplifies the concept of Signature Client Service through outstanding, personalized customer service skills
• 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
• Function as regional external liaison with assigned Diagnostic Client representatives (e.g., Diagnostic CRA, Site Monitors, Study Managers), the PM Global Study Manager and the internal clients to ensure outstanding - timely communication
• Accountable of the proper and timely delivery of all the regional study related aspects and deliverables from winning 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
• Function as a remote regional liaison between Global Study Manager and the various internal departments involved in the study.
• Participate in Labcorp 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

• Day-to-day local study related activities- including but not limited to: (80% of time in a single work week)
• Prepare, organize and host CRA visits as needed.
• Participate in 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 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
• 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
• Participating in team meetings and taking minutes
• Organize and Archiving study documentation and correspondence as requested by the client
• Filling 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

• Bachelor's degree in biology, Chemistry, or other Life Science; or Medical Technology degree.
• 5 years of clinical laboratory experience or customer service experience, preferably in the pharmaceutical industry.
• Experience with multidisciplinary lab background preferred
• Professional certification (ASCP, PMP or other) in area(s) expertise preferred