Global CDx Study Manager

Posted 3 Days Ago
Be an Early Applicant
Indianapolis, IN, USA
In-Office
Senior level
Healthtech • Biotech
The Role
Manage regional and global companion diagnostic (CDx) study activities from award through closeout, coordinate CRO/CRA/site interactions, support database and regulatory submissions, maintain study documentation and billing, ensure harmonized laboratory processes and compliance, and act as primary client liaison to deliver studies on scope, schedule, and budget.
Summary Generated by Built In

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

Job Responsibilities

  • 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.
  • Function as a 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.

Minimum Qualifications

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

Preferred Qualifications

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

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.

Skills Required

  • 5+ years clinical laboratory or customer service experience
  • Bachelor's degree in biology, chemistry, life science, or Medical Technology degree
  • Experience with regulatory submissions and maintaining compliance
  • Experience managing study documentation, audit readiness, and record keeping
  • Ability to coordinate and host CRA visits and client audits
  • Experience supporting database design and implementation
  • Strong verbal, written, and interpersonal communication skills
  • Ability to manage high-volume administrative workload and meet timelines
  • Effective collaboration within global, cross-functional, and virtual teams
  • Multidisciplinary lab background (1+ year)
  • Professional certification (ASCP, PMP or other)
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The Company
HQ: Burlington, NC
19,796 Employees
Year Founded: 1978

What We Do

We believe in harnessing science for human good. And so we work day and night, around the world, to deliver answers for all your health questions—whether you’re a provider, drug developer, hospital, medical researcher or patient. That means everything from advancing diagnostic testing to helping launch new drugs, to offering new perspectives through data - all drawing from a deep well of scientific expertise. So when you need trusted information to make clear, confident health decisions, consider us your source.

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