Manager, Biosample Operations


Manager, Biosample Operations
Brisbane, CA 


Seeking a Manager, Biosample Operations whose primary function will be to manage the lifecycle of all clinical specimens to ensure samples are collected, processed, and stored with the highest degree of quality.

Responsibilities:
Accountable for planning, organizing and overseeing the collection and shipping of samples from investigator sites or Central Labs and their subsequent delivery to assay laboratories to ensure timely delivery and optimal analyzable quality
  • Maintain oversight of all study sample operational activities and regularly report on status, including sample collection and reconciling against consent
  • Manage relationships with laboratory vendors, including forecasting and tracking of study costs associated with sample management
  • Review protocol and Informed consent form to ensure feasibility of biological sampling and alignment with ICH/GCP and sample testing plans
  • Review laboratory manuals and laboratory specification materials to ensure accuracy and consistency with the study protocol and clinical needs
  • Participate in CRF development to ensure laboratory sample information is collected for sample tracking and reconciliation purposes
  • Drafting RFPs and manage scopes of work in support of study objectives for central and specialty labs
  • Develop study-specific sample management plans to document cross-functional agreements on the lifecycle and reconciliation plan for each sample type
  • Facilitate sample shipments and query resolution among vendors to ensure timely data delivery
  • Support sample analysis data transfer, data reconciliation, and data review
  • Maintain professional knowledge of current GCP, biobanking, and sample management best practices and ethical guidelines and apply knowledge appropriately
 
Qualifications
  • Bachelor's, or equivalent, degree in a scientific discipline
  • Demonstrated understanding of pharmaceutical regulatory requirements, both US and abroad
  • Demonstrated knowledge of ICH and GCP
  • Effective team player and ability to collaborate with cross functional clinical study teams
  • Ability to manage lab vendors and oversee sample management activities across multiple clinical trials
  • Demonstrated ability to work independently to manage complex projects with multiple priorities in a fast paced, team-based environment
  • Excellent written and interpersonal communication skills necessary to interface with vendors and team members
  • Direct experience in managing sample operations of various sample types
  • Experience with vendor and CRO management
  • Proficient with sample data reporting, managing metrics and understanding the overall quality and stability of study samples
  • Proven critical reasoning skills including the identification and resolution of complex problems
  • Able to travel 10%-20%

Job Details

Job Type: Contract
Location: Richmond, CA
Job ID: 19-10899
Date Updated: October 29, 2019