Global CDx Study Manager Diagnostic Dvpt Svcs

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.

• 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.

• 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.

• 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

• 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

• 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

• 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.