Senior Regional CDx Study Manager

Responsibilities / Duties：

The CDx (Companion Diagnostic) Regional Study Coordinator II is responsible for the successful delivery of the study management activities related to diagnostic studies in their specific area of the world.

The CDx Regional Study Coordinator II coordinates, plans, organizes, and oversees the completion of administrative and technical tasks during the Dx study lifetime in collaboration with the Principal Investigator, the regional laboratory testing site, and the various internal departments involved in the deliverables of the study.

The CDx Regional Study Coordinator II ensures three-way communication with the regional Diagnostic Client, the PM Global Study Manager appointed to the Pharma Sponsor, and the regional laboratory operations testing site.

The CDx Regional Study Coordinator II acts as a consultant/Technical Expert in providing recommendations/advice to all parties, managing, planning, and coordinating all projects related, as well as maintaining study documentation in accordance with customer expectations and in compliance with regulatory requirements.

General duties:

1. Act as ambassador on behalf of the Diagnostic client across Covance departments; exemplifies the concept of Signature Client Service through outstanding, personalized customer service skills.
2. 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) to develop solutions, resolve issues, and approve internal database loading/design plans.
3. Act as regional external liaison with assigned Diagnostic Client representatives (e.g., Diagnostic CRA, Site Monitors, Study Managers), the PM Global Study Manager, and the internal clients to ensure outstanding and timely communication.
4. 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 by working in close collaboration with the PM Global Study Manager and the Diagnostic Global Study Managers.
5. Review the Diagnostic component of the 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.
6. Act as a remote regional liaison between the Global Study Manager and the various internal departments involved in the study.
7. Participate in Covance CLS development through continuous process improvement, quality, and productivity.
8. Demonstrate through appropriate self-organization the ability to manage a high administrative load.
9. Able to act efficiently in an environment with dynamic timelines and priorities.
10. 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 in and prepare Client Audit related to Diagnostic studies.
• Prepare, coordinate, set up, and 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 and lead 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.
• Ensure that all customer expectations are documented and acted upon in compliance with regulatory requirements.
• Serve as backup to Client Coordinator Specialists and Regional Study Coordinators.

Study Coordinators 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 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.

Education / Qualifications：

Minimum Required:

• Medical Technology (MT) degree or Bachelor’s Degree or Equivalent Experience.

Preferred:

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

Experience：

Minimum Required:

3 years of clinical laboratory experience or customer service experience, preferably in the pharmaceutical industry. Experience with multidisciplinary lab background is a plus.

Labcorp is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Labcorp strives for diversity and inclusion 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 of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), 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

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