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.
Job Responsibilities- 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.
Minimum Qualifications- Medical Technology degree; or Bachelor's degree
- 3 or more years of experience in a clinical laboratory environment or customer service environment.
- 2 or more years experience in project management
Preferred Qualifications- 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
Additional Job Standards- 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%
About the RoleThe 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 be based on a candidate's skills and prior relevant experience, applicable degrees/certifications, as 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, please click here.