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

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 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

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
• 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

Thrive personally and professionally at Labcorp

Working at Labcorp you will continue to grow in our learning-based culture so you will know how to respond and adapt expertly 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 peoples lives.

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

What we are looking for

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

Experience & Education Requirements:

• Bachelors 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

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 60000 employees serving clients in more than one hundred countries as we work together to make a real impact on peoples lives.

Pay Range: $90000 - $110000

All job offers will bebased on a candidates skills and prior relevant experience applicabledegrees/certificationsas 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 more detailed information pleaseclick here.

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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