The Biospecimen Operations Associate (Client) is an important member of the Operations group in Clinical Biospecimen Management (CBM). The Client has an active cross-functional role and supports the Biospecimen Operations Manager (BOM) throughout the entire life cycle of a clinical protocol, i.e., Protocol Concept & Study Start-up, Enrollment & Maintenance, and Close-Out Phases. The Client will assist the crafting of the appropriate study documentation that accurately reflects BioMarin's ethical and operational expectations as needed so that the BOM can communicate and manage operational issues to a mutually acceptable conclusion between the vendor, the Study Execution Team (SET) and the scientists.
- Provide support to the BOM with SET related activities and participate in relevant cross functional meetings, as needed, throughout the life-cycle of a clinical trial
- Prepare dashboards and trends for BOM to present at the SET
- Review biospecimen handling sections of ICF template; provide input and guidance to Clinical Operations (CLO) on any site, country or EC specific modifications to the ICF
- Update biospecimen metrics tracker with relevant ICF information to document any issues impacting ability to collect, store, or use biospecimens
- 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.
- Maintain relevant documentation in clinical biospecimen inventory tracking system
- Documentation and escalation of unresolved operational issues to BOM.
- Perform continuous tracking of clinical trial collected biospecimens.
- Support BOM with biospecimen tracking and reconciliation activities for all assigned studies in BioMarin's in-house clinical biospecimen inventory tracking IT system.
- Fulfill analysis requests for use of samples
- Maintain the scope of work between the external biorepository and BioMarin, which will be captured in the biorepository operation documentation.
- Manage escalated queries generated by biorepository upon receipt of BioMarin samples, working with appropriate parties to resolve in a timely manner
- Identify, track and resolve queries for key samples required for Analysis Requests to meet testing timelines
- Escalate queries that cannot be resolved within an agreeable timeframe to the BOM
- Address biospecimen related queries from Translational Sciences/Research such as biospecimen inventory reports or clarification of the assays for which the biospecimens were collected.
- Work with relevant parties to track biospecimen specific information such as volume, freeze-thaws cycles, current location to assist researchers with selecting of biospecimens for testing
- Identify missing information pertaining to biospecimens (e.g. discrepant biospecimen IDs, missing visit information, etc)
- Participate in CBM functional process improvement projects, as needed.
Individuals in the BOM role are expected to demonstrate foundational Communication, Teamwork and Problem Solving skills, including:
- Actively contributing to cross-functional team definition of goals, roles and tasks.
- Proactively developing 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 track action items assigned during meetings
The Client should demonstrate knowledge across all primary technical competencies, including Biospecimen Management Processes, Vendor Management and Lab Operations, Good Practices and Compliance, and Drug Development. This includes:
- Understanding of end-to-end biospecimen management lifecycle, i.e., biospecimen collection, processing, storage and shipping.
Understanding informed consent and its impact on biospecimen management.
- 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.
- BA/BS in life sciences or related degree. Experience in lieu of education accepted.
- 2 years of relevant experience working in the pharmaceutical industry (including CROs, clinical sites, labs and biorepositories).
- 1 year of relevant technical experience working with biospecimen management, lab management, biobanking, or similar organizations.
- 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.
The Client will work closely with other members of the CBM team and cross-functional groups such as:
- Internal: Information Management (IM), Development Sciences Operations (DSO), Legal, Compliance, Clinical Data Management (CDM), Translational Sciences (TS), Biomarker Discovery, Clinical Sciences (CLS), Global Regulatory Affairs, Global Medical Affairs (GMAF), and Human Resources.
- External: Central and Specialty Laboratories, and biorepository's project managers, counterparts or appropriate team members at partner companies and if necessary CRAs.
No people management responsibilities.