Translational Medicine Lab Manager

Summary of Position

The Translational Medicine Lab Manager is responsible for managing the lifecycle of laboratory samples, vendor management, development and maintenance of relevant SOPs, and process improvement initiatives in support of our Translational Medicine activities. This individual will work closely with the Translational Medicine laboratory staff and lab vendors to manage translational research laboratory activities including translational research sample management and translational research data transfers to meet departmental deliverables. They will also support clinical laboratory activities related to clinical study closeout.

The Translational Medicine Lab Manager reports functionally to the Head of Clinical Laboratory, however, for activities related to the translational research laboratory, directions and oversight will be provided by the Translational Biomarker lead and the Vice President of Translational Medicine.

Responsibilities and Job Duties

• Translational Medicine sample management activities include sample receiving, sample accessioning, sample discrepancy resolution, sample data reconciliation, sample disposition, outbound sample shipping and associated documentation for Translational Medicine.
• Coordinates shipment of translational research samples between the translational research lab, central laboratories, and third-party laboratories.
• Collaborates with Clinical Operations, third-party vendor laboratories, central laboratories, and research laboratory staff on specimen management activities.
• Supports translational clinical study data review, transfer, and archiving.
• Manages vendor activities associated with translational research assays:
  
  
  
  • In collaboration with Translational biomarker lead, ensures contracts reflect the necessary requirements and are in compliance with the study protocol
  • Ensures testing timelines are aligned with departmental needs
  • Serves as the primary contact for vendors
  
  
  
  
• Supports issue resolution and data reconciliation in collaboration with data management and translational research laboratory staff.
• Develops necessary processes and applicable SOPs to support maintenance of sample chain of custody within the research laboratory and third-party vendor laboratories.
• Supports clinical laboratory related clinical study closeout activities.
• Adheres to safety and compliance requirements.
• Other activities as required.

Minimum Qualifications

Education & Experience

• Bachelor's degree, preferably in health care, life sciences, or related discipline
• Minimum of five years of professional level experience with sample management, equipment management and/or sample analysis. Experience in a regulated clinical or biological laboratory is strongly preferred.
• Experience with clinical study sample coordination related to early and late phase clinical trials
• Experience working in GxP environment with knowledge of regulatory compliance requirements

Knowledge, Skills and Abilities

• Excellent verbal and written communication skills
• Working knowledge of GxP regulations
• Vendor management experience
• Experience writing and maintaining SOPs
• Knowledge and working experience with LIMS - based systems
• Knowledge of the chain-of-custody of clinical biospecimen management from collection, process, transportation, receiving, storage, destruction through long-term retention
• Ability to multitask and prioritize activities in a fast-paced environment with awareness of deadlines
• Excellent organizational skills
• Proven ability to work independently
• Experience working in a matrix environment

Supervisory Responsibilities

• N/A
  
  

Additional Information

The annual rate of pay for the Translational Medicine Lab Manager position ranges from $109,800 - 167,500. For non-exempt roles, and according to applicable regulations, there may be the possibility for overtime pay. This role is eligible for the Company's discretionary bonus and discretionary equity incentives. Eligible employees may participate in the Company's benefits programs, including medical / dental / vision / prescription coverage, employee wellness resources, 401(k) plan with employer match, access to an Employee Stock Purchase Plan, (ESPP), paid time off & paid parental leave benefits, and disability benefits.

The annual pay rate range is described in good faith, and the Company believes is the range of possible compensation for this role at the time of this posting depending on the candidate's experience, qualifications, geographic location, and other factors permitted by law. The Company may ultimately pay more or less than the posted range, and this range may be modified in the future. No amount is considered to be wages or compensation until such amount is earned, vested, and determinable under the terms and conditions of the applicable policies and plans. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.