Regional Study Manager Companion Diagnostics

vor 2 Monaten

Genf GE, Schweiz Labcorp Vollzeit

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.

**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
- 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 docum

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