Global CDx Study Manager Diagnostic Dvpt Svcs

Global CDx Study Manager Diagnostic Dvpt Svcs Labcorp - 3.3 Indianapolis, IN Job Details Full-time 6 hours ago Benefits Employee stock purchase plan Disability insurance Health insurance Dental insurance 401(k) Tuition reimbursement Paid time off Vision insurance Qualifications Project team coordination Meeting minutes Biology Research design Customer relationship building Medical Technology ASCP Certification Inventory management Adverse event reporting Customer service Bachelor of Science Corrective and preventive actions (CAPA) Mid-level Client relationship development Improving operational efficiency 3 years Bachelor's degree in biology Clinical laboratory experience Key Performance Indicators Bachelor's degree Quality improvement Research compliance clinical trial records management Organizational skills Document archiving Chemistry Regulatory submissions Budgeting Research budget management Regulatory audits Cross-functional collaboration Full Job Description Labcorp is seeking a Global CDx Study Manager II to join our team at 8211 Scicor Drive, Indianapolis, Indiana . Work Schedule Monday - Friday, day shift Job Responsibilities Key Responsibilities Serve as an ambassador for the Diagnostic client, delivering exceptional, personalized customer service across internal departments. Function as primary regional liaison between sponsors, study managers, investigators, labs, and cross-functional teams to ensure clear communication and issue resolution. Manage regional study execution from award through close-out, ensuring deliverables are on time and within budget. Review Statements of Work for feasibility and provide recommendations on study design. Support global consistency of diagnostic programs across sites, including process harmonization's and protocol alignment. Develop, monitor, and act on performance metrics; implement corrective and preventive actions as needed. Collaborate with commercial teams and clients during pre-award phases. Manage and monitor study budgets in partnership with global study leadership. Drive continuous process improvement, quality, and productivity initiatives. Day-to-Day Operations Coordinate study timelines and activities with labs, CRAs, and internal teams. Lead and participate in client meetings, audits, and site visits. Submit regulatory applications and ensure compliance with applicable requirements. Track billable activities and study progress metrics. Report adverse events and protocol deviations to appropriate stakeholders. Ensure customer requirements are documented and met in line with regulatory standards. Provide backup support for study coordinators and global study managers. Documentation & Compliance Maintain and organize study documentation (e.g., binders, logs, material tracking forms) Support audit readiness, documentation filing, and archiving. Track inventory and study materials as required. Participate in team meetings, including minute-taking and reporting. Skills & Experience Strong project management and organizational skills with ability to manage high workload volumes. Excellent communication and people skills, with proven ability to build relationships. Ability to operate effectively in a fast-paced, dynamic environment with shifting priorities. Strong mindfulness and commitment to quality and regulatory compliance Minimum Qualifications BS degree in Biology, Chemistry, or other Life Science; or Medical Technologist degree. 3 or more years of clinical laboratory experience or customer service experience Preferred Qualifications Professional certification (ASCP, PMP or other) in area(s) expertise 3 or more years experience working within a multidisciplinary laboratory 3 or more years experience in pharmaceutical industry Additional Job Standards Strong verbal, written, and interpersonal communication skills. Proven ability to deliver exceptional customer service with integrity and professionalism. Effective collaborator within global, cross-functional, and virtual teams Strong client-facing presence with excellent relationship-building skills Demonstrated negotiation and constructive persuasion abilities. Elevated level of initiative with the ability to work both independently and collaboratively. Strong leadership skills, fostering teamwork across study teams and laboratory sites. Ability to build and maintain internal and external relationships to ensure timely, on budget delivery. Adaptable communicator with a collaborative mindset and focus on achieving shared goals. About Labcorp At Labcorp, we are a global leader of innovative and comprehensive laboratory services that help doctors, hospitals, pharmaceutical companies, researchers, and patients make clear and confident decisions. Through our unparalleled diagnostics and drug development laboratory capabilities, our 70,000 employees combine innovative innovation, science and technology to solve some of today's biggest health challenges, accelerate life-changing healthcare breakthroughs and impact lives around the world. Here, you are empowered to own your career journey and create a personalized development plan with the support of your team.

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. 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 If you are an individual with a disability who needs assistance using our online tools to search and apply for jobs, or needs an accommodation, please visit our accessibility site or contact us at Labcorp Accessibility. For more information about how we collect and store your personal data, please see our Privacy Statement.