Global Study Manager

If you are looking for a company where you can personally advance healthcare and make a difference in peoples’ lives with your bold ideas and unique point of view, consider working at Labcorp as a Global Study Manager for our Diagnostic Development Services department.

In this role, you will be responsible for the successful delivery of the study management activities related to companion diagnostic studies in their specific area of the world.

You will coordinate, plan, organize and oversee the completion of administrative and technical tasks during the companion diagnostic study life time in collaboration with the Principal Investigator, the laboratory testing sites and the various internal or external stake holders involved in the deliverables of the study.

You will ensure the three ways communication with the regional Diagnostic Client, the Global Study Manager appointed to the Pharma Sponsor and the regional diagnostic testing laboratories.

You will also 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.

In more details, you will… 

Day-to-day local study related activities- including but not limited to:(90% of time in a single work week)

• Set up the Diagnostic study accordingly to Pharmaceutical requirements and guidelines

• Coordinate and manage the communication between the different stake holders (Pharmaceutical and Diagnostic sponsors’ teams, Diagnostic Labs, Clinical Investigator CROs and Clinical Central Lab CROs)

• Gather and compile data inputs received from the external stake holders.

• Monitor data revived from the Pharmaceutical sponsors accordingly to QC data monitoring procedures, guidelines and escalation plans of the Pharmaceutical sponsor

• Triage and send queries to the different stake holders above mentioned in order to resolve issues identified during the monitoring with

• Manage data reconciliation accordingly to sponsors’ requirements and in compliance with Pharmaceutical sponsors procedures

• 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

• Global Study Management responsibilities:

• Ensure laboratory processes harmonization across Lab Diagnostic sites location.

• Ensure Diagnostic protocols and program consistency across Lab Diagnostic sites location

• Ensure proper escalation of internal or external misalignment and inconsistencies; propose corrective and preventive actions

• Manage, monitor sponsors’ Budgets in coordination with the PM global study manager

Regulatory/ Study Documentation duties-(10% 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

• 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

• 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’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. 

What we’re looking for  

Global Study Managers are the most successful at Labcorp with:  

• BS degree with Master Science in Biology, Chemistry or other Life Science or PhD.

• 2 years of previous experience in clinical Project Manager role OR 5 years of clinical laboratory experience or customer service experience, preferably in pharmaceutical industry. Experience with multidisciplinary lab background.

• Experience in design and development of molecular assays and or histopathology assays (IHC: Immunohistochemistry) preferred

• Experience working in a regulated environment preferred (GLP, cGMP, CLIA)

• Molecular assay validation experience (per FDA design control &ISO regulation) a plus

• Data processing basing knowledge

• Microsoft Office Tools, Excel, PowerPoint, MS Project literate

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. We encourage all to apply.

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Salary : $103,000 - $130,000