Senior Regional CDx Study Manager

Senior Regional CDx Study Manager I

The Senior Regional CDx Study Manager I is responsible for the successful delivery of the study management activities related to diagnostic studies in their specific area of the world. This role coordinates, plans, organizes and oversees, in his regional location, the completion of administrative and technical tasks during the Dx study life time in collaboration with the Principal Investigator, the regional laboratory testing site and the various internal departments involved in the deliverables of the study. The Senior Regional CDx Study Manager I also maintains a tight collaboration with the other study coordinators counterparts to align processes and production activities.

This position will be based from our Scicor drive location in Indianapolis, IN. This role is eligible for a hybrid work schedule (2 days from home a week).

General Duties:

• Act as ambassador on behalf of the Diagnostic client across Labcorp departments; exemplifies the concept of Signature Client Service through outstanding, personalized customer service skills.
• Provide information related to Dx studies in order to maintain accurate study tracker and workload activities information.
• Act as regional internal liaison to ensure proper and smooth communication between the Diagnostic Sponsor, the PM Global Study Manager, the Principal Investigators/Scientists, the laboratory operation and the various internal departments involved in the study (Quality Assurance, Commercial Development, Global Laboratory Services Support, Specimen Storage, Data Management, Client Services, Information Technology) develop solutions, resolve issues and approve internal database loading/design plan
• Act as regional external liaison with assigned Diagnostic Client representatives (e.g. Diagnostic CRA, Site Monitors, Study Managers) to ensure an outstanding and timely communication and deliverables
• Accountable of the proper and timely delivery of all the regional study related aspects and deliverables from win study notice to the closure of the study by working in close collaboration with the PM Global Study Manager and the Diagnostic Global Study Managers
• Review the Diagnostic component of study Statement of Work to ensure local feasibility and make appropriate recommendations to the Study Design Lead in collaboration with the PM Global Study Manager and the DDS Global Study Manager
• Act as a remote regional liaison between Global Study Manager and the various internal departments involved in the study.
• Participate in Labcorp development through continuous process improvement, quality and productivity
• Demonstrate through appropriate self-organization the ability to manage high administrative load
• Able to act efficiently in an environment with dynamic timelines and priorities
• Demonstrate strong interpersonal and communication skills that will build strong internal and external relationships to ensure deliverables are on time and within budget

Principal Day-to-Day Duties Day-to-day local study related activities- including but not limited to: (80% of time in a single work week)

• Prepare, organize and host CRA visits as needed.
• Participate into and prepare Client Audit related to Diagnostic studies
• Monitors study timelines and ensure proper coordination with the regional laboratory testing site, the CRA and all internal departments involved.
• Submit regulatory authority applications
• Manage external and internal meetings
• Track monthly Diagnostic services billable activities
• Report Adverse Events as needed to the global diagnostic Study Manager and Principal Investigator/Scientist
• Report protocol deviations as needed to the global diagnostic Study Manager and Principal Investigator/Scientist
• Serve as back up to Regional CDx Study Manager and Senior Regional CDx Study Manager II as needed

Regulatory/ Study Documentation Duties-(20% of time in a single work week)

• Maintain all necessary study documentation, including but not limited to: study binders,
• material receipt forms, and material balance forms.
• Organize and Archiving study documentation and correspondence as requested by the client
• Filing and collating trial documentation and reports
• Perform physical inventory of study materials as needed

Required Education & Work Experience:

• Associate of Medical Technology (MLT) degree or Bachelor's Degree or Equivalent Experience required; Medical Technology (MT) degree or University degree (BS) in a scientific field preferred
• 2 years of clinical laboratory experience or customer service experience, preferable in pharmaceutical industry. Experience with multidisciplinary lab background is a plus.

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.

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.

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