Job Description

TITLE : BIOSPECIMEN OPERATIONS MANAGER

LOCATION: SAN RAFAEL,CA, 94903

DURATION: 12 MONTHS

SUMMARY:

The Biospecimen Operations Manager (BOM) is a critical member of the Operations group in Clinical Biospecimen Management (CBM). The BOM has an active cross-functional role throughout the entire life cycle of a clinical protocol, i.e., Protocol Concept & Study Start-up, Enrollment & Maintenance, and Close-Out Phases. He/she will participate in the crafting of the appropriate documentation for the central and specialty laboratories that accurately reflects Client’s’s ethical, contractual, financial, and operational expectations as needed so the BOM can appropriately communicate and manage operational issues to a mutually acceptable conclusion between the vendor, the Study Execution Team (SET) and the scientists.

RESPONSIBILITIES:

·         Provide input during vendor selection process for new or former central and specialty labs considered for Client’s clinical trials.

·         Participate in the central and specialty laboratories sourcing process that includes identification, evaluation, and selection of vendors that would be the best fit for each study’s needs and documenting recommendations and decisions.

·         Establish various documents and plans to ensure Client’s’s and vendor’s expectations are aligned so vendor performance and quality metrics are developed, agreed and implemented.

·         Participate in and/or lead vendor conference calls on relevant topics.

·         Act as SET point of contact for vendor management throughout life of a protocol.

·         Report relevant vendor questions/issues to SETs and other cross-functional teams as needed.

·         Perform the initial vendor invoice review and payment from the internal accounting system and provide input to CLO for their final approval of pending invoices.

·         Maintain trackers of biospecimen-related information.

·         On vendor activity and biospecimen sample handling.

·         To consult on decisions regarding biospecimen collection, kit design, shipping schedule, and data deliverables.

·         In the evaluation of site performance for protocol-defined lab procedures.

·         On ICF wording of biospecimen-related sections to ensure defined standards are met.

·         Entry of study-related data in the clinical biospecimen inventory tracking system for each supervisor-assigned study prior to First Patient In (FPI).

·         Set-up and maintain all planned biospecimen-relevant information including details for each biospecimen collected.

·         Leverage input for more accurate price alignment between central and specialty lab cost proposals with actual biospecimen and testing needs.

·         Manage biospecimen tracking and reconciliation activities for all assigned studies in Client’s’s in-house clinical biospecimen inventory tracking IT system.

·         Act as the first point of contact for biospecimen requests, e.g., Analysis Request (AR), fulfillments.

·         Review shipping requirements and ensure shipping manifest aligns for all labs.

·         Develop a scope of work between the external biorepository and, which will be captured in the biorepository operation documentation. 

·         Facilitate inquiries related to the appropriateness or integrity of biospecimens, work with CBM Steward on disposal requests as appropriate.

Participate in CBM functional process improvement projects, as needed.

SKILLS:   

·         Manage existing central and specialty laboratories to address any operational questions/issues that arise and resolve or triage to the appropriate individual or cross-functional group.

·         Participate in SET and other cross functional meetings as a standing member throughout the life-cycle of a clinical trial to providing input:

·         Documentation and escalation of unresolved operational issues to department senior management and SET Lead.

·         Collaborate with CBM and data management teams, along with vendors for appropriate documentation and plans of biospecimen inventory and testing results.

·         Perform continuous tracking of clinical trial collected biospecimens.

·         Consult on internal and external training documentation on biospecimen management procedures and proper completion of biospecimen transfer documents.

SKILLS

·         Individuals in the BOM role are expected to demonstrate foundational Communication, Leadership, and Problem Solving skills and advanced Teamwork skills, including:

·         Actively contributing to cross-functional team definition of goals, roles and tasks.

·         Proactively expanding one’s network and work relationships outside the department.

·         Ability to create inclusive and collaborative cross-functional team and meeting environments.

·         Ability to recognize and articulate and prioritize key issues that arise based on understanding of objectives so that issues are resolved.

·         Ability to analyze and evaluate problems and seek-out and recommend possible solutions before escalation.

·         Leveraging data effectively to communicate points of view and influence outcomes.

·         Effectively lead meetings, track action items.

DESIRED SKILLS:

The BOM should demonstrate advanced knowledge across all primary technical competencies, including Biospecimen Management Processes, Vendor Management and Lab Operations, Good Practices and Compliance, and Drug Development. This includes:

·         Comprehensive understanding of end-to-end biospecimen management lifecycle, i.e., biospecimen collection, processing, storage, shipping and destruction.

·         Comprehensive understanding informed consent and its impact on biospecimen management.

·         Comprehensive understanding of managing central and specialty lab’s handling of biospecimens, biospecimen collection kits, protocol deliverables, timelines and test results as related to the 3 phases of a clinical trial, i.e., Protocol Concept & Study Start-up, Enrollment & Maintenance, and Close-Out Phases.

·         Solid understanding of GxP principals and how they impact biospecimen operational and vendor management activities, and what appropriate steps and path need to be taken to escalate.

·         Understanding of study protocol objectives and methodology.

·         Comprehensive understanding of financial documents.

EDUCATION:         

·         BA/BS in life sciences or related degree. Experience in lieu of education accepted.

·         6 years of relevant experience working in the pharmaceutical industry (including CROs, clinical sites, labs and biorepositories).

·         4 years of relevant technical experience working with biospecimen management, lab management, biobanking, or similar organizations.

EQUIPMENT:

·         Computer work utilizing common business software programs.

·         Experienced in the following software: Microsoft Office Products including Visio, Project, Teams, and SharePoint; Labmatrix to track biobank biospecimens and processes; and Monday.com for project management.

·         The employee must occasionally lift and/or move up to 25 pounds.  Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.