Senior Regional Study Manager Companion Diagnostics

Labcorp is a global leader in laboratory services providing the insights and answers that help healthcare providers patients researchers pharmaceutical companies and health systems make confident decisions and improve outcomes. Through our unparalleled science data technology and laboratory network we advance diagnostics accelerate innovation and help address some of the worlds most important health challenges. As we shape the future of healthcare we are leveraging advanced technologies intelligent digital solutions and data-driven innovation across our operations to enhance how work gets done and deliver greater value to customers and patients. With our global scale and deep expertise youll have the opportunity to do meaningful work grow your career and make a real impact on peoples health around the world. Together were improving health and improving lives.

Labcorp is seeking an onsite Senior Regional Companion Diagnostic Study Manager to join our team in Torrance CA.

Work Schedule: Standard business hours of Monday through Friday 8:00 a.m. to 5:00 p.m.. Business needs may occasionally require flexibility in work hours including earlier later or additional hours with reasonable notice provided when possible.

Work location: Torrance CA lab location (19750 S. Vermont Avenue Torrance CA 90502 Ste. 200). This is a hybrid role where you potentially can work 2 days remotely.

• Coordinate plan organize and oversee regional companion diagnostic (CDx) study activities from study initiation through study closure.
• Manage regional study deliverables in partnership with Global Study Managers Diagnostic Study Managers Principal Investigators and laboratory operations teams.
• Serve as the primary regional liaison among diagnostic sponsors Global Study Managers laboratory testing sites and internal support functions.
• Review diagnostic components of Statements of Work to assess local feasibility and provide recommendations on study execution.
• Monitor study timelines and coordinate activities across laboratory operations clinical research associates and internal stakeholders.
• Prepare organize and host client and clinical research associate site visits.
• Support and participate in client audits related to diagnostic studies.
• Submit regulatory authority applications and support compliance-related activities.
• Lead and coordinate internal and external project meetings.
• Track diagnostic services billing activities and related study metrics.
• Report adverse events and protocol deviations to designated study leadership and investigators.
• Ensure customer expectations study requirements and deliverables are documented and executed in accordance with regulatory requirements.
• Maintain study documentation including study binders material receipt forms material accountability records and correspondence.
• Organize file archive and retrieve study documentation and reports.
• Perform physical inventory activities for study materials as needed.
• Serve as backup support for Regional CDx Study Managers and Senior Regional CDx Study Managers.
• Contribute to process improvement quality initiatives and operational efficiency efforts.

• Medical Technology degree; or Bachelors degree
• 3 or more years of experience in a clinical laboratory environment or customer service environment.
• 2 or more years experience in project management

• Professional certification such as ASCP PMP or other relevant certification.
• University degree(BS) in a scientific field
• 2 or more years of experience with multidisciplinary lab background

• Ability to read write and communicate professionally in English.
• Experience supporting pharmaceutical industry projects.
• Experience working within multidisciplinary laboratory environments.
• Knowledge of clinical trial processes diagnostic studies and regulatory requirements.
• Ability to build and maintain productive relationships with clients investigators laboratory operations teams and cross-functional stakeholders.
• Strong project management organization and prioritization skills.
• Ability to manage multiple projects timelines and competing priorities in a dynamic environment.
• Strong verbal and written communication skills.
• Ability to identify issues develop solutions and facilitate resolution across stakeholder groups.
• Experience working with study documentation records management and audit support activities.
• Computer proficiency and ability to work with business and project management systems.
• Ability to influence and collaborate with internal and external stakeholders.
• ability to travel up to 10%

The Senior Regional CDx Study Manager is an individual contributor responsible for the successful execution of regional companion diagnostic studies. The role serves as a key connection point between diagnostic sponsors laboratory operations Principal Investigators and project teams to ensure study objectives timelines quality standards and regulatory requirements are met. This position supports regional operations while collaborating closely with global study leadership and cross-functional stakeholders throughout the study lifecycle.

Pay Range: $78K -$94K

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.Employees regularly scheduled to work less than 20 hours Casual Intern and Temporary employees are only eligible to participate in the 401(k) Plan.For 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.

We encourage all to apply

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