Senior Regional CDx Study Manager

Labcorp • Indianapolis, IN

81d

About The Position

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 counter parts 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).

Requirements

• 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.

Responsibilities

• 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.
• Develop solutions, resolve issues and approve internal database loading/design plan.
• Act as regional external liaison with assigned Diagnostic Client representatives to ensure outstanding and timely communication and deliverables.
• Accountable for the proper and timely delivery of all the regional study related aspects and deliverables from win study notice to the closure of the study.
• Review the Diagnostic component of study Statement of Work to ensure local feasibility and make appropriate recommendations.
• 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.
• Prepare, organize and host CRA visits as needed.
• Participate into and prepare Client Audit related to Diagnostic studies.
• Monitor 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.
• Maintain all necessary study documentation, including but not limited to: study binders, material receipt forms, and material balance forms.
• Organize and archive study documentation and correspondence as requested by the client.
• File and collate trial documentation and reports.
• Perform physical inventory of study materials as needed.

Benefits

• 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
• Education Level: Bachelor's degree