Get ready to redefine what's possible and discover your extraordinary potential. Here at Labcorp, you'll have the opportunity to personally advance healthcare and make a difference in peoples' lives with your bold ideas and unique point of view. With the support of exceptional people from across the globe and an energized purpose, you'll be empowered to own your career journey with mentoring, training and personalized development planning.
Join us as we speed the delivery of groundbreaking therapies and anticipate tomorrow's drug development challenges, creating new possibilities for our clients-and your career.
The Company - LabCorp
As one of the world's largest and most comprehensive drug development services companies, LabCorp has helped pharmaceutical and biotech companies develop one-third of the all prescription drugs in the marketplace today.
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The Position
This position falls within our Central Labs Services group supporting the Diagnostic Development Services. This is an onsite position.
About the Job
As a Regional Study Manager Companion Diagnostics, you are responsible for the successful delivery of the study management activities related to diagnostic studies in their specific area of the world.
You coordinate, plan, organize and oversee, in the 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.
You ensure the three ways communication with the regional Diagnostic Client in their specific area of the word, the Project Management Global Study Manager appointed to the Pharma Sponsor and the regional laboratory operations testing site.
You act 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.
- 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
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 CDx Study Manager and Senior Regional Study Managers I.
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.
- 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
Your background and skills
- Minimum a Medical Technology (MT) degree or Bachelor's degree in a scientific field
- Minimum 3 years of clinical laboratory experience or clinical studies experience with project management responsibilities
- Experience with multidisciplinary lab background is a plus
- Excellent communication and organization skills
- Demonstrated time management skills
- Dedicated to teamwork
- Ability to plan and prioritize
- Thrive in a fast-paced environment
- Excellent customer facing experience
- Experience with Companion Diagnostic studies is preferred
- Professional certification (ASCP,PMP or other) in area(s) expertise is preferred
- Geneva site: qualification by the Foederation Analyticorum Medicilanium Helveticorum (FAMH) or by the Foederation Medicorum Helveticoruma (FMH) is preferred
- Fluency in English and French
Thrive personally and professionally at Labcorp
Working at Labcorp, you'll 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'll 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 team-oriented environment.
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 100 countries, as we work together to make a real impact on people's lives.
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.
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