• Job Description

  Req#: 2439553

  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 point of view, consider working at Labcorp as a Global Study Manager for 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 Study Manager (CDx) 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 Study Manager (CDx) 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 a hybrid position requiring 3 days, each week, onsite at our Torrance, CA location.

  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 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
  • 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

  Principal Day-to-Day duties include:

  • 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

  Study Management responsibilities include:

  • 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

  Regulatory/ Study Documentation responsibilities (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

  Thrive personally and professionally at Labcorp

  Working at Labcorp, you will continue to grow in our learning-based culture, so you’ll know how to expertly respond and adapt as the industry continues to evolve. Here, you will put your education to work as you play a meaningful role in advancing healthcare and making a difference in people’s life.

  In addition, Labcorp offers great benefits, global experience, and the opportunity to work independently within a collaborative environment.

  What we are looking for

  Our CDx Global Study Managers are most successful at Labcorp with:

  Experience & Education Requirements:

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

  Get to know Labcorp

  At Labcorp, we believe in the power of science to change lives. We are a leading global life sciences company that delivers answers for crucial health questions. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations that not only empower patients and providers but help medical, biotech, and pharmaceutical companies transform ideas into innovations.

  Here, you can join our more than 60,000 employees, serving clients in more than one hundred countries, as we work together to make a real impact on people’s lives.

  Pay Range: $90,000 - $110,000

  All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as, internal equity and market data.

  Benefits: Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan. Casual, PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible to participate in the 401(k) Plan only. For more detailed information, please click here .

  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

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• About the company

  Laboratory Corporation of America Holdings, more commonly known as Labcorp, is an American S&P 500 company headquartered in Burlington, North Carolina.

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