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 world's 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, you'll have the opportunity to do meaningful work, grow your career and make a real impact on people's health around the world. Together, we're 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. 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 Role 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, a #J-18808-Ljbffr LabCorp