Global CDx Study Manager Diagnostic Dvpt Svcs

Labcorp•Indianapolis, IN

3d•Onsite

About The Position

Labcorp is seeking a Global CDx Study Manager II to join their team in Indianapolis, Indiana. This role serves as a key liaison between sponsors, study managers, investigators, labs, and cross-functional teams, ensuring clear communication and issue resolution. The Study Manager is responsible for managing regional study execution from award through close-out, ensuring deliverables are met on time and within budget. This includes reviewing Statements of Work, supporting global consistency of diagnostic programs, developing and monitoring performance metrics, and collaborating with commercial teams during pre-award phases. The role also involves managing study budgets, driving continuous process improvement, and ensuring compliance with regulatory standards.

Requirements

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
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.
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.

Nice To Haves

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

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.