Senior Regional Study Manager II

Labcorp • Indianapolis, IN

35d • Onsite

About The Position

Are you interested in making a real scientific impact through your everyday work? Would you enjoy working in a team-focused environment as you explore unique career opportunities? If you are looking for a company where you can personally advance healthcare and have an influence on people’s lives with your bold ideas and unique point of view, consider working at Labcorp as a Senior Regional Companion Diagnostics (CDx) Study Manager II. The Senior Regional CDx Study Manager II leads regional diagnostic study operations, overseeing planning, coordination, and execution throughout the study lifecycle. This role serves as the primary regional liaison between the Diagnostic Client, Global Study Manager, and laboratory teams while providing technical expertise, ensuring regulatory compliance, and maintaining high‑quality study documentation. This position will be office based at our Scicor Drive location. In more details, you will… Key Responsibilities: Serve as the regional liaison between the Diagnostic Sponsor, Global Study Management, Principal Investigators, laboratory teams, and internal departments. Deliver all regional study activities and milestones on time, from study awards through closeout. Represent the Diagnostic client across Labcorp teams and provide exceptional customer service. Support feasibility review of study SOWs and provide regional recommendations. Coordinate communication across internal functions, including QA, Commercial Development, Specimen Storage, Data Management, IT, and others. Prepare for and host CRA visits and participate in client audits. Coordinate study timelines and ensure alignment with regional lab operations and internal partners. Submit regulatory authority applications and ensure compliance with all study requirements. Lead and manage external and internal study‑related meetings. Track monthly billable activities and report adverse events or protocol deviations. Ensure customer expectations are documented and followed in accordance with regulations. Maintain and archive essential study documents, including binders, forms, and correspondence. Conduct physical inventories of study materials and manage documentation filing. Provide backup support to Regional CDx Study Managers and Senior Regional Study Managers I. Contribute to ongoing process improvement and organizational development. Maintain strong organizational skills to manage a high administrative workload and shifting priorities. Build effective relationships to support on‑time, and on budget study execution. Thrive personally and professionally at Labcorp Working at Labcorp, you will continue to grow in our learning-based culture, so you will know how to respond and adapt expertly as the industry continues to evolve. Here, you will put your education to work as you play a meaningful role in advancing healthcare and making a difference in people’s lives. In addition, Labcorp offers great benefits, global experience, and the opportunity to work independently within a collaborative environment.

Requirements

• 3 years of clinical laboratory experience or customer service experience, preferably in pharmaceutical industry.
• Experience with multidisciplinary lab background is a plus.
• Medical Technology (MT) degree or bachelor’s degree or Equivalent Experience

Nice To Haves

• Computer literate
• University degree (BS) in a scientific field is a strong plus.
• Professional certification (ASCP, PMP or other) in area(s) expertise

Responsibilities

• Serve as the regional liaison between the Diagnostic Sponsor, Global Study Management, Principal Investigators, laboratory teams, and internal departments.
• Deliver all regional study activities and milestones on time, from study awards through closeout.
• Represent the Diagnostic client across Labcorp teams and provide exceptional customer service.
• Support feasibility review of study SOWs and provide regional recommendations.
• Coordinate communication across internal functions, including QA, Commercial Development, Specimen Storage, Data Management, IT, and others.
• Prepare for and host CRA visits and participate in client audits.
• Coordinate study timelines and ensure alignment with regional lab operations and internal partners.
• Submit regulatory authority applications and ensure compliance with all study requirements.
• Lead and manage external and internal study‑related meetings.
• Track monthly billable activities and report adverse events or protocol deviations.
• Ensure customer expectations are documented and followed in accordance with regulations.
• Maintain and archive essential study documents, including binders, forms, and correspondence.
• Conduct physical inventories of study materials and manage documentation filing.
• Provide backup support to Regional CDx Study Managers and Senior Regional Study Managers I.
• Contribute to ongoing process improvement and organizational development.
• Maintain strong organizational skills to manage a high administrative workload and shifting priorities.
• Build effective relationships to support on‑time, and on budget study execution.

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.
• Casual, PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible to participate in the 401(k) Plan only.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level