SummaryTango Therapeutics has an exciting new opportunity for a Senior Specialist, Biosamples to join the Companion Diagnostics and Clinical Biomarkers Team and support multiple clinical trials. This is a matrixed role relying on partnerships with internal stakeholders and external collaborators, biorepositories, laboratories, and contract research organizations (CROs). Working collaboratively across functions, you will ensure implementation, compliance, and support of clinical biosample plans and management for early phase and late-stage trials in Tango's clinical portfolio.
Your Role:- Accountable for tracking, coordinating and overseeing all operational activities required to manage the lifecycle of clinical biosamples, ensuring sample integrity and GCP compliance throughout the process.
- Oversee shipment and receipt of clinical biosamples, document chain of custody throughout all stages of the clinical workflow and respond to issues as needed to ensure biosample custody is protected.
- Coordinate with internal and external stakeholders to manage the timely shipment of clinical samples, leveraging sample forecasts and inventory availability to support study milestones and laboratory testing needs.
- Manage relationships with laboratory and clinical study personnel internally and at external clinical sites, contract laboratories, and contract research organizations (CROs).
- Oversee compilation, quality control, and integration of cumulative inventory reports from external laboratories into Tango's internal LIMS database.
- Conduct periodic audits of biosample inventory for each clinical program, and prepare audit summaries for relevant stakeholders.
- Independently collaborate with internal and external stakeholders to rapidly address biosample queries and facilitate data discrepancy resolution, as needed.
- Maintain effective verbal and written communication internally and with external collaborators and vendors.
- Ensure compliance and proper documentation in accordance with work instructions, SOPs, and all applicable regulations.
What You Bring:- Minimum of a Bachelor's degree in a life science concentration
- 3+ years clinical research experience
- Biotech or pharmaceutical sponsor experience highly preferred
- Experience working with contract research organizations (CROs), central laboratories and third party clinical laboratories
- Demonstrated familiarity with LIMS databases and other biosample tracking tools and systems
- Solid understanding of good clinical practice (GCP/ICH) and good clinical laboratory practice (GCLP)
- Strong communication, impeccable attention to detail, and outstanding follow-through
- Ability to learn independently on the job in a face paced environment
Salary range
$90,400-$135,600 USD
