Global CDx Study Manager

Global CDx Study Manager I

Labcorp is seeking a Global CDx Study Manager I to join our team at 8211 Scicor Drive, Indianapolis, Indiana.

Work Schedule:

Monday – Friday, day shift.

Serve as a Diagnostic client ambassador across Labcorp, delivering Signature Client Service through personalized, high‑quality customer engagement.

Function as a regional internal liaison, ensuring seamless communication between Diagnostic Sponsors, Global Study Managers, Principal Investigators, laboratory operations, and key internal functions (QA, Data Management, IT, Client Services, etc.).

Partner cross‑functionally to develop solutions, resolve issues, and support database design and implementation.

Act as the primary external point of contact for Diagnostic client stakeholders (CRAs, Study Managers, Site Monitors), ensuring initiative‑taking and timely communication.

Ensure on‑time delivery of regional study activities and milestones from study award through closeout.

Review and assess Diagnostic components of Statements of Work (SOWs) for feasibility; provide recommendations to study design leadership.

Support continuous improvement initiatives to enhance quality, efficiency, and productivity.

Demonstrate strong organizational skills to manage high‑volume administrative workload in dynamic environments.

Build and maintain strong internal and external relationships to ensure delivery within scope, timeline, and budget.

Global Study Management (as assigned):
Ensure global consistency of diagnostic programs across testing sites, including harmonization of laboratory processes; establish and monitor performance metrics, implementing corrective actions as needed; provide pre‑award consultation support with clients and commercial development teams; partner with Global Study Managers to manage and track Diagnostic Sponsor budgets.

Day‑to‑Day Study Operations (≈80%):
Coordinate and host CRA visits and client audits; develop, manage, and track study timelines and deliverables across lab sites and stakeholders; submit regulatory applications and maintain compliance with applicable requirements; lead and facilitate internal and external study meetings; track and report on Diagnostic services billing activities; report adverse events and protocol deviations to appropriate stakeholders; ensure all customer requirements are documented and met in compliance with regulations;

provide backup support to Study Coordinators and Study Managers as needed.

Documentation & Regulatory Support (≈20%):
Maintain complete and accurate study documentation (binders, material tracking, inventory records); support audit readiness and documentation compliance; organize, file, and archive study records and correspondence; record meeting minutes and track action items; perform inventory tracking of study materials; ensure accurate monthly tracking of billable activities.

• 5 or more years of clinical laboratory experience or customer service experience.
• Bachelor’s degree in biology, chemistry, or another life science, or a Medical Technology degree.

• 1 or more years of experience with a multidisciplinary lab background.
• Professional certification (ASCP, PMP, or other) in area(s) of expertise.

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.

• Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement, and Employee Stock Purchase Plan for…