Biospecimen Senior Specialist (Clinical Sample Acquisition)
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Job Location:
Pleasanton, CA - USA
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
At Roche you can show up as yourself embraced for the unique qualities you bring. Our culture encourages personal expression open dialogue and genuine connections where you are valued accepted and respected for who you are allowing you to thrive both personally and professionally. This is how we aim to prevent stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche where every voice matters.
The Position
Biospecimen Senior Specialist (Clinical Sample Acquisition)
Department Summary
Biospecimens are among Roches most valuable physical assets; samples with associated data are critical to all phases of Research and Development (R&D) this role you will support Pleasantons 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. BAM is a global service function supporting the acquisition characterization and management of human and non-human biological materials.
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 biospecimensfrom quality checks and data imports to inventory exportswhile upholding the highest standards of data privacy Good Clinical Practices (GCP) Good Laboratory Practices (GLP) and regulatory compliance to safeguard patient trust.
This position is based inPleasanton CA on site (3 days a week on site approximately).
The Opportunity
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.
Who You Are (Required)
You have a Bachelors 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.
Preferred Skills Knowledge and Qualifications
You have an advanced degree in a scientific discipline.
You have prior experience navigating a highly complex global environment to align cross functional stakeholders.
Experience in SQL Python and R ispreferred.
Your skills will help transform fragmented vendor provided datasets into a standardized data manifest ensuring that every sample used by Roche is ethically and legally compliant.
Relocation benefits are not available for this position.
The expected salary range for this position is based on the primary location of California- USD Annual. Actual pay will be determined based on experience qualifications geographic location and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.
This position also qualifies for the benefits detailed at the link provided below.
Who we are
A healthier future drives us to innovate. Together more than 100000 employees across the globe are dedicated to advance science ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities foster creativity and keep our ambitions high so we can deliver life-changing healthcare solutions that make a global impact.
Lets build a healthier future together.
Roche is an equal opportunity employer. It is our policy and practice to employ promote and otherwise treat any and all employees and applicants on the basis of merit qualifications and competence. The companys policy prohibits unlawful discrimination including but not limited to discrimination on the basis of Protected Veteran status individuals with disabilities status and consistent with all federal state or local laws.
If you have a disability and need an accommodation in relation to the online application process please contact us by completing this form Accommodations for Applicants.
Required Experience:
Senior IC
About Company
F. Hoffmann-La Roche AG is a Swiss multinational healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has bearer shares listed on the SIX Swiss Exchange. The company headquarters are located in Basel.
