Biospecimen Senior Specialist (Clinical Sample Acquisition)

Benefits

Qualifications

• •You have a Bachelor's degree in a scientific discipline
• •You have 3 years experience applying broad knowledge in molecular biology or clinical studies along with an understanding of medical device development (especially assays) or experience in the technical and ethical aspects of biospecimen utilization, clinical operations, or sample management
• •You are someone who has experience in clinical data management, clinical research, clinical trial operations or biospecimen management
• •You have demonstrated success being part of a high-performing team environment, thinking strategically and excelling in cross-functional collaboration
• •You are someone who is committed to developing your skills to better yourself and your team
• •2 more items(s)

Responsibilities

• •In this role, you will support Pleasanton’s Biospecimen Acquisition and Management (BAM) subchapter as a Biospecimen Senior Specialist
• •BAM is strategically positioned within the Development Services and Integration (DSI) chapter of Roche Diagnostics Solutions’ R&D organization
• •Reporting to the BAM Acquisition Team Lead, you will oversee clinical biospecimen and data requests across a diverse project portfolio
• •You will provide end-to-end management of the acquisition lifecycle, ensuring seamless delivery to key stakeholders
• •By collaborating with local and global partners, you will align sample requirements with internal processes and industry standards
• •This role includes managing end-to-end data integrity of the acquired biospecimens—from quality checks and data imports to inventory exports—while upholding the highest standards of data privacy, Good Clinical Practices (GCP), Good Laboratory Practices (GLP) and regulatory compliance to safeguard patient trust
• •End-to-End Workflow Management: Drive the full lifecycle of sample acquisition and data management to ensure customer requests are fulfilled accurately and on time
• •GxP Compliance & Data Integrity: Manage information within LIMS frameworks, maintaining rigorous documentation standards and data quality in accordance with validated GxP regulations
• •Cross-Functional Leadership: Partner with R&D, Legal, and Logistics teams to align project requirements, manage global stakeholders, and represent the focus area in high-level meetings
• •Strategic Problem Solving: Serve as a Subject Matter Expert (SME) to guide decision-making, manage complex requests autonomously, and influence project strategy through scientific expertise
• •Risk & Agility Management: Proactively identify and escalate project risks while adapting to shifting priorities to meet strict deadlines and quality standards
• •8 more items(s)