Central Laboratory Manager

Category:

Life Science

Employment Type:

Contract

Reference:

BH-392073

Yoh presents an excellent long-term Central Laboratory Manager
opportunity with a trusted, long-term client located in Swiftwater, PA.

This position is part of a major pharmaceutical company, and requires a p roject management experience. Schedule is full-time M-F (7am-8am start time, 8 hour shift)
and may require flexibility to work some evenings and overtime due to projects.

Key Responsibilities:

• Act as the interface between assigned clinical study personnel (i.e., Immunoleads, Biosamples Leads and Strategic Alliance Managers, etc.) and clinical operations (e.g., Global Study Managers, Clinical Logistics Managers, etc.), plus data/quality management personnel and the Project Manager (PM), to support the central laboratory activities for the vaccines R&D clinical portfolio.
• Attend weekly or bi-monthly PM-led central laboratory status update meetings for assigned clinical studies.
• Ensure adherence to clinical study timelines by tracking the progress of the central laboratory activities and reporting milestone completion as appropriate to impacted personnel.
• Escalate issues to Central Laboratory Head and PM for resolution guidance and instructions.
• Resolve issues and report lessons learned to the Central Laboratory Head; Support and or lead lessons learned discussions with impacted personnel.
• Support and, where applicable, coordinate logistical operations, including study startup activities, human biological laboratory specifications, sample management activities, testing, purchasing, and import of related reagents to support clinical testing.
• Collaborate with personnel to ensure proper import/export permits are issued in appropriate countries for the collection and transport of human biological samples.
• Work with Biosamples Leads and Strategic Alliance Managers to verify sample chain of custody is maintained with internal and external laboratories.
• Support the resolution of site inquiries and operational issues in a timely manner by consulting with the Project Manager and responsible clinical operations personnel.
• Support investigations of deviations from established procedures to ensure effective corrective actions are implemented.
• Contribute to the authoring of key documents to support internal and external clinical testing, including Central Laboratory Specifications/Manuals and Analytical Test Plans.
• Support special projects that impact the End-to-End Sample Management and Testing (SMaT) Initiative (e.g., process improvement working groups, sample trackers, custom reports, etc.).

• PMP certification preferred.
• Experience in project management within the pharmaceutical industry.
• Experience with tracking timelines and coordinating logistical operations.
• Working knowledge of clinical operations.
• Ability to communicate effectively with team members.

• Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
• Health Savings Account (HSA) (for employees working 20+ hours per week)
• Life & Disability Insurance (for employees working 20+ hours per week)
• MetLife Voluntary Benefits
• Employee Assistance Program (EAP)
• 401K Retirement Savings Plan
• Direct Deposit & weekly epayroll
• Referral Bonus Programs
• Certification and training opportunities