Biosample Operations Manager

Location
San Francisco, CA
Posted
Nov 30, 2018
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

Description

The Biosample Operations Manager (BOM) will be responsible for the biosample operations logistics and management.   He/she will enable the maximal use of the clinical trial samples and ensure that Portola processes follow the ethics and compliance guidelines around patient samples. Finally the individual will be responsible for facilitating the governance on sample usage.

Overall responsibilities will include planning, coordinating, and overseeing all operational activities required to manage the lifecycle of biosamples (including participating in laboratory selection and oversight, collection, processing, analysis, data receipt and final repository). This role will provide biosample operational expertise and ensure the program infrastructure can scale to meet Portola’s needs. This position reports to the head of Clinical Operations and works closely with multiple internal teams and external partners on Portola-sponsored trials, research and product development teams.

Responsibilities:

  • Serve as primary point of contact for laboratories performing biomarker analysis and hence supports the biomarker outsourcing process through effective vendor management
  • Participate in the identification, selection and operational oversight of laboratory vendors including drafting RFPs and defining scope of work in support of study objectives and goals
    • Partner with internal teams to understand and meet sample demand
    • Work with internal technical experts to ensure appropriate documentation/validations are in place and to define key sample criteria
    • Perform accurate forecasting and tracking of study costs associated with sample and result management, bioanalytical assays, sampling materials, logistics & shipping as needed
  • Accountable for establishing sample collection, processing, and shipping instructions from investigative sites
    • Provide input to clinical study protocol and ICF with respect to collection feasibility of biological sampling; provide input on sampling aspects relevant to site feasibility and selection
    • Provide education and training materials for sample collection, handling and shipment
    • Participate in the CRF development process to ensure lab sampling information is appropriately collected for sample tracking and reconciliation purposes
  • Actively partner with Data Management to establish quality and completeness metrics/reports, data format and delivery timelines
    • Review quality and completeness metrics to monitor effectiveness of investigator site sample handling training and quality of samples received and recommend corrective action as necessary
    • Provide progress updates on collection, assay status, analysis updates; support data transfer, data review and reconciliation activities
  • Lead the development and finalization of the Biosample Management Plan (BMP) based on input from scientific and operational stakeholders, to include strategy for a scalable sample storage, tracking and access
  • Write and review SOPs and working practices

Qualifications:

  • BS/BA in Life Science or related discipline
  • 5+ years industry experience in drug development
  • 5+ years clinical or biological laboratory experience with evidence of involvement in the processing and/or analysis of biological samples
  • Strong working knowledge of FDA & ICH/GCP regulations and guidelines
  • Effective team player and ability to collaborate with cross functional clinical study teams
  • Ability to manage lab vendors and oversee biosample 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 outside vendors, consultants, and team members
  • Strong organization, documentation and presentation skills across multiple priorities
  • Working knowledge of Microsoft Office Suite with emphasis on Excel skills