• Serve as BMS for one program (all studies) or select studies across multiple programs as necessary.
• Perform continuous tracking of clinical trial collected biospecimens and related logistics, issues and queries from the planning stage to final disposition.
  • Support biospecimen tracking and reconciliation activities in BioMarin’s in-house clinical biospecimen inventory tracking IT system.
• Review and become familiar with Central lab and Specialty lab documentation to understand the pathway and biospecimen lifecycle (collection, processing, analysis, data delivery process and final sample disposition) for assigned studies.
• Input, maintain & understand all biospecimen-relevant information in CLBM/BioMarin systems for clinical trial studies, including: outlining biospecimen stakeholder contacts, number and quantity of each biospecimen collected as related to the study’s schedule of events, any unique biospecimen handling or operational requirements, details of testing destinations and related shipping requirements.
• Respond to queries generated by biorepository upon receipt of BioMarin samples.
• Assist in performing super user tasks, including but not limited to: updating CBMS: Labmatrix, BioMarin’s IT software that tracks study specific biospecimen inventory and operational workflow information, based on study-relevant documents:
  • Gathering and documenting user requirements for ad-hoc and custom reports
  • Loading data from internal & external sources/systems (manual and/or automatic)
  • Flagging issues for other CLBM staff or labs/biorepositories for investigation and resolution in order to ensure timely, efficient, high-quality data
  • Assist in the maintenance of records
• Support the set-up and maintenance of repository of all biospecimen-relevant collection and processing information.
• Collaborate with Central and Specialty Laboratories including long term biorepository vendor for biospecimen tracking. Proficient in use of central lab systems to pull reports and view data as appropriate.
• Support the set-up and maintenance of vendor workspaces.
• Responsible for biospecimen management, storage, and/or destruction per requirements and escalate and inform as needed.
• Maintain an accurate, up-to-date inventory within central biospecimen database.
• Ensure sample integrity and maintain GCP/GLP for samples through chain of custody, sample handling guidelines, and proper storage conditions.
• Escalate issues that cannot be resolved within established timelines
• Accurately follow department SOPs related to Biospecimen Management.
• Work with appropriate CLBM staff to fulfill biospecimen analysis requests and facilitate returns.

Skills

• Prepare accurate biospecimen manifests for outgoing shipments for analysis requests.

• Assist CLBM and/or biorepository staff with special technical projects and infrastructure processes as assigned.
• Track sample analysis and data transfer deliverables using reports and metrics from vendors; ensure timely shipments to vendors and/or storage sites and that the data are transferred in support of data deliverables (i.e., snapshots, DBLs) and routine clinical study support.
• Upload biospecimen related documents to the Trial Master File, ensuring that documentation standards are followed and are ‘inspection-ready’.
• Understand ICH/GCP/GLP, storage procedures, biospecimen management best practices and ethical guidelines. Serve as a subject matter expert (SME) and resource for biospecimen management.
• Assist in the development of site facing and/or participant support tools for complex biospecimen collection and processing training purposes as needed
• Support process improvement initiatives or improving efficiency as needed.
• Share ideas and work product with competence in a clear, concise, and timely way.
• Proactively recognize, articulate and prioritize key issues and identify risks based on understanding of objectives.
• Analyze and evaluate problems and seek-out and recommend possible solutions before escalation.
• Leverage data effectively to communicate and influence outcomes.
• Effectively track action items assigned during meetings.
• Other duties related to CLBM remit may be assigned.

Education

• Bachelor’s degree in biology, medical technology, or related field or equivalent combination of education and experience.
• 2 years of relevant experience working in the pharmaceutical industry, related field and/or training (including CROs, clinical sites, central and specialty labs, and biorepositories). 
• 2 years of relevant technical experience, ideally working with biological samples which includes but not limited to biospecimen management, biobanking, or similar organizations.
• Working knowledge of human biospecimen sample types and associated storage/shipment conditions.
• Proficient in performing tasks that require a strong attention to detail ensuring high quality outputs.
• Technical knowledge to maintain electronic files of large datasets and proficient with data entry and manipulation
• Experience in the following software preferred:
  • Microsoft Office Products including Excel, Word, PowerPoint, Visio, Project, Teams, and SharePoint; Individuals should be proficient with Microsoft Excel in particular including lookups, matching, and comparison tools and have a basic understanding of relational databases and integration between systems.
  • Sample tracking/LIMS: including but not limited to Labmatrix for tracking biobank biospecimens and processes; central lab systems.
  • Project management software such as Monday.com, Smartsheet.
• Excellent organization skills, ability to meet tight deadlines and to quickly adapt to changing priorities.
• Ability to work effectively in a cross-functional team matrixed environment.
• Knowledge and understanding of clinical drug development strategic planning of clinical research, ICF, ICH GCP, GLP, In Vitro Diagnostic Regulation (IVDR) 2017/746, General Data Protection Regulation (GDPR) and clinical laboratory specimen handling.
• Advanced planning and organization skills.
• Excellent analytical and assessment skills.

• Commitment to teamwork and strong “can do” attitude, seeks change & values innovation.