The Global CDx Study Manager I is responsible for the successful delivery of the study management activities related to diagnostic studies in their specific area of the world.
The Global CDx Study Manager I coordinates, plans, organizes and oversees, in his 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.
The Global CDx Study Manager I 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.
The Global CDx Study Manager I 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.
General duties:
Act 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
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 Labcorp 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 Global CDx Study Manager I may be assigned with Global
Study Management duties.
In his Global Study Manager role, the Global CDx Study Manager I is accountable to:
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
Principal Day-to-Day duties
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 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 sites location.
Ensure Diagnostic protocols and program consistency across 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-(20% of time in a single work week)
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
Minimum Required:
5 years of clinical laboratory experience or customer service experience, preferable in pharmaceutical industry. Experience with multidisciplinary lab background is a plus.
Education/Qualifications/Certifications and Licenses
Minimum Required:
BS degree in Biology, Chemistry or other Life Science; or Medical Technology degree.
Preferred:
Computer literate
Professional certification (ASCP,PMP or other) in area(s) expertise