The 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 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 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.
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The 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.
C. Essential Job Duties:
General duties:
- Act as ambassador on behalf of the Diagnostic client across Covance 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 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.
- In his Global Study Manager role, the 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
I. Experience:
Minimum Required:
5 years of clinical laboratory experience or customer service experience, preferable in pharmaceutical industry. Experience with multidisciplinary lab background is a plus.
III. 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
Labcorp is proud to be an Equal Opportunity Employer:
Labcorp strives for inclusion and belonging 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 and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), 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. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law.
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