Clinical Laboratory & Biospecimen Management (CLBM) is a group within Strategic Research and Development Operations (SRDO) that provides effective and efficient vendor oversight (operational, contractual, and financial) for Central and Specialty Laboratories involved in all stages of BioMarin’s clinical trials. CLBM is organized to focus on both Biospecimen Management and Vendor Operations with dedicated resources for:

1. Biospecimen Management

2. ECD/Study Start-Up

3. LCD/Study Maintenance & Close-Out Ultimately, CLBM ensures the ethical collection, analysis, and lifecycle tracking of human biospecimens to deliver timely data in support of clinical protocol timelines.

The Vendor Laboratory Manager (VLM) is a critical member of CLBM accountable for the performance of both central and specialty laboratories. The VLM 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. The VLM will participate in the crafting of the appropriate documentation for the central and specialty laboratories that accurately reflects BioMarin’s ethical, contractual, financial, and operational expectations. The VLM is expected to have ownership to ensure assigned vendor deliverables and timelines are clear, vendor resources are appropriately planned and managed, and communications and escalations are effective. The VLM should manage any operational issues to a mutually acceptable conclusion between the vendor, the Study Execution Team (SET) and the scientists.

Perform the following responsibilities independently with limited oversight from Associate Directors and/or Senior Managers:

· Provide vendor oversight in compliance with BioMarin's processes and procedures with central and specialty laboratories for clinical studies across all stages, in accordance with the appropriate quality standards including ICH/GCP/GLP and applicable regulations.

· Understand scope of work and intended use for clinical lab and biomarker assays as defined by the clinical protocol and including study protocol objectives.

· Establish various documents and plans to ensure BioMarin’s and vendor’s expectations are aligned (i.e., Communication Plan, Sample Analysis Plan, etc.).

· Effectively lead vendor meetings, track action items and manage deliverables. Hold vendor accountable for agreed upon milestones, metrics and reportables. Drive action items to completion.

· Ensure collection, delivery and analysis of biospecimens under the highest standards of quality, ethics, and informed consent at study level in collaboration with key SMEs.

· Review informed consents and its impact on biospecimen management.

· Proactively identify and resolve and/or escalate study-related issues (within 24 hours) with CLBM Management.

· Identify and communicate risks. Proactively develop risk mitigation plans and communicate plan timely and effectively. Execute and close-out mitigation plans.

· Document and escalate unresolved operational issues to department senior management and SET Lead (within 24 hours). Communicate plan for resolution and accountable for close-out with respective corrective action/preventative action (CAPA).

· Support quality activities: document vendor issues, investigations, corrective and preventive actions.

· Perform vendor invoice review, accruals and invoice reconciliation. Communicate variances in the budget as appropriate.

· Work with cross-functional areas to continuously improve processes.

· Participate in SET and other cross functional meetings as a standing member throughout the life cycle of a clinical trial to provide study level updates, inform on central and specialty lab vendor performance and highlight risk.

· Drive implementation and execution of biomarker strategy: biospecimen collection, kit design, biospecimen kit logistics, shipping schedule, and data deliverables.

· Manage the development and oversight of the analysis and data delivery timelines in accordance with internal decision making/governance meetings.

· Inform key stakeholders (assay owner, Global Study Operations (GSO) and Clinical Sciences (CLS)) of site performance for protocol-defined lab procedures, sample or data quality metrics.

· Review and provide input into biospecimen related portions of protocols, informed consents and other ethics committee/regulatory documents, laboratory documents, case report forms, and service provider laboratory scope of work documents.

· Collaborate with CLBM, CLS, GSO and data management teams, along with vendors for appropriate documentation and plans of biospecimen inventory and testing calculations, flags and results.

· Participate in Investigator meetings, CRO kick-off meetings; author and deliver presentations and trainings to internal and external stakeholders on complex sample collection and handling procedures, as applicable.

· Inform on expected blood volumes for central and specialty assays as defined by the clinical protocol.

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

· Utilize departmental tools to track and manage biospecimen-related deliverables and timelines.

· Document and understand study specific information which includes assay intended use, priority, endpoints, specimen flow and data management pathways.

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

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

· Participate in CLBM functional process improvement projects, as needed.

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

· Other duties related to CLBM remit may be assigned.

· Master’s Degree with life sciences/laboratory background, including biomarkers and 3+ years project management, and/or clinical operations experience.

· Bachelor’s Degree with life sciences/laboratory background, including biomarkers and 5+ years project management, and/or clinical operations experience.

· Clinical or biological laboratory experience with evidence of involvement in the processing and/or analysis of biological samples. Working knowledge of human biospecimen sample types and associated storage/shipment conditions.

· Relevant professional experience working in the pharmaceutical/biotechnology industry, clinical research setting or clinical/diagnostic/central or specialty laboratory which includes specimen management, biomarker operations, vendor management, translational sciences operations, clinical operations.

· Strong 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), clinical laboratory specimen handling and able to determine a test’s intended use.

· Planning, organizational and effective time management skills with an ability to adapt to changing priorities; excellent analytical and interpersonal skills.

· Detail oriented with the ability to work with minimal supervision and manage multiple competing priorities.

· Critical reasoning skills including the identification and resolution of complex problems.

· Strong problem-solving skills are required.

· Experience with risk identification, mitigation planning, management and execution.

· Experience with issue resolution and close-out.

· Comprehensive understanding of financial and contract documents.

· Professional interpersonal skills, excellent oral/written communication and influencing skills.

· Experience holding meetings by teleconference and working with colleagues remotely.

· Effectively work in a cross-functional team environment and ability to interact with various levels within the organization as well as vendors.

· Project management skills, PMP certification preferred.

· Experience in the following software preferred:

· Microsoft Office Products including Excel, Word, PowerPoint, Visio, Project, Teams, and SharePoint;

· 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