Biosample Operations Senior Associate / Manager

California Life • South San Francisco, CA

86d • $100,000 - $144,000

About The Position

Calico is seeking a Biosample Operations Senior Associate / Manager to manage the lifecycle of clinical samples, from patient to data. This position will be responsible for managing biosample collection, processing, shipment, tracking, storage, and analysis while ensuring compliance with clinical protocols, regulatory requirements and ethical standards. The ideal candidate will work closely with cross-functional teams including Clinical Operations, Data Management, Biomarker Scientists, Biostatistics, and external vendors.

Requirements

• Bachelor's degree in a life sciences discipline or related field
• Minimum of 5 years' experience in laboratory setting or sample management within the biotechnology or pharmaceutical industry
• Demonstrated understanding of ICH, GCP, and GLP guidelines
• Excellent organizational, interpersonal, and communication skills
• Strong proficiency with electronic data management systems (LIMS) and sample tracking software
• Proficiency with Microsoft Office, advanced Microsoft Excel skills preferred
• Demonstrated ability to establish priorities, work independently and collaborate effectively with the cross-functional team and external partners/vendors
• Must be willing to work onsite at least four days a week

Nice To Haves

• Previous oncology drug development experience
• Prior experience building LIMS system

Responsibilities

• Coordinate biosample logistics from clinical sites to central labs and analysis laboratories
• Manage query resolution and documentation
• Contribute to development of biosample management plans (BMPs), study protocols, ICFs, lab manuals and other relevant study documents
• Collaborate with Biomarker and Clinical teams to ensure sample and data delivery and support data analysis and interpretation
• Assist with process improvement activities for biosample operations including development of vLIMS and biomarker data management systems to ensure traceability and accurate documentation
• Participate in study team meetings and provide updates on sample operational status
• Ensure compliance with clinical trial protocols, regulatory guidelines, and Good Clinical Practice (GCP)

Benefits

• Eligible for two annual cash bonuses

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Insurance Carriers and Related Activities
• Education Level: Bachelor's degree
• Number of Employees: 251-500 employees