Senior Biospecimen Specialist
About The Position
As a Biospecimen Senior Specialist within the Biospecimen Acquisition and Management (BAM) subchapter, you will play a pivotal role in fueling Roche’s Research and Development (R&D) innovation by managing the end-to-end lifecycle of critical biological assets. You will lead the design, planning, and execution of sample acquisition, ensuring that materials are procured and characterized in strict alignment with global regulatory standards, including Good Clinical Practice (GCP), Good Clinical Practice (GLP), and ethical guidelines. By collaborating with a diverse network of internal and external stakeholders, you ensure that the biological needs of R&D teams are met efficiently while upholding Roche’s core quality principles. In addition to acquisition, you will serve as a Laboratory Information Management System (LIMS) Power User responsible for the integrity and security of biospecimen data. This involves overseeing data entry, performing complex imports and quality checks, and ensuring all information adheres to Findability, Accessibility, Interoperability, and Reuse (FAIR) data principles and privacy regulations such as General Data Protection Regulation (GDPR) and Health Insurance Portability and Accountability Act (HIPAA). You will be expected to operate with high autonomy—proactively managing risks, resolving data discrepancies, and aligning with global teams to ensure that biospecimen data remains a high-quality, reusable asset that supports the development of future diagnostic solutions. This position is based in Pleasanton, CA, on site.
Requirements
- Bachelor's degree in a scientific discipline.
- 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.
- Experience in clinical data management, clinical research, clinical trial operations or biospecimen management.
- Demonstrated success being part of a high-performing team environment, thinking strategically and excelling in cross-functional collaboration.
- Committed to developing your skills to better yourself and your team.
Nice To Haves
- Advanced degree in a scientific discipline.
- RMSCC, microbiology, bacteria, or cell knowledge background is highly preferred.
- Prior experience navigating a highly complex, global matrix environment to align cross functional stakeholders.
- Experience in SQL, Python and R.
- Data wrangling and data processing in R/Python to support the summarization and interpretation of clinical trial data.
- Experience wrangling data from disparate sources, data cleaning, and harmonizing datasets for analysis.
Responsibilities
- Orchestrate sample acquisition and biological material fulfillment, ensuring customer requirements are met through cross-functional partnership with R&D, Legal, and Logistics.
- Manage complex information within LIMS and other databases, adhering to strict validated standards and GxP regulatory requirements.
- Design and implement new applications and guidelines to streamline data collection, manipulation, and analysis of complex datasets.
- Oversee rigorous data review and collaborate with external providers to resolve ambiguities and reconcile inconsistent data into high-quality structures.
- Act as a subject matter expert in global stakeholder meetings, proactively managing risks and delivering project outcomes with minimal oversight.
Benefits
- A discretionary annual bonus may be available based on individual and Company performance.
- Benefits detailed at the link provided below.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Number of Employees
5,001-10,000 employees
