Biosamples Operations Lead, Clinical Trials

Tango Therapeutics; Boston (MA); On-site; USD 90,000 - 136,000; Full time

Job summary

Tango Therapeutics has a Senior Specialist, Biosamples opening to join the Companion Diagnostics and Clinical Biomarkers Team and support multiple clinical trials. The role is matrixed, partnering with internal teams, external collaborators, biorepositories, labs, and CROs to ensure biosample plans are implemented and compliant.

You will track the biosample lifecycle, oversee shipment and custody, coordinate with stakeholders to meet study milestones, and maintain robust documentation and data

Qualifications

• Bachelor’s degree in life science
• 3+ years clinical research experience
• Biotech or pharmaceutical sponsor experience highly preferred
• Experience working with CROs, central laboratories and third party clinical laboratories
• Familiarity with LIMS databases and other biosample tracking tools and systems
• Solid understanding of GCP/ICH and GCLP
• Strong communication, impeccable attention to detail, and outstanding follow-through
• Ability to learn independently on the job in a fast-paced environment

Responsibilities

• 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.

Skills

LIMS knowledge

GCP/ICH knowledge

Documentation

Communication skills

Vendor coordination

Attention to detail

Education

Bachelor’s degree in life sciences

Job description

Tango Therapeutics has a Senior Specialist, Biosamples opening to join the Companion Diagnostics and Clinical Biomarkers Team and support multiple clinical trials. The role is matrixed, partnering with internal teams, external collaborators, biorepositories, labs, and CROs to ensure biosample plans are implemented and compliant.

You will track the biosample lifecycle, oversee shipment and custody, coordinate with stakeholders to meet study milestones, and maintain robust documentation and data