Biosample Operations Associate

Denali Therapeutics; South San Francisco (CA); On-site; USD 140,000 - 190,000; Full time

Job summary

Denali seeks a skilled biospecimen operations manager to oversee the Biorepository and Clinical Study Management teams, ensuring sample integrity, regulatory compliance, and efficient processes to support clinical research. You will coordinate biospecimen data management, lead improvements, mentor staff, and ensure GCP compliance while collaborating across functions in a fast-paced environment.

This role requires a Bachelor's in a life sciences field, at least five years in translational

Qualifications

• Bachelor's degree in a life sciences field is required.
• Minimum 5 years' experience in translational medicine or clinical development.
• Proficiency with LIMS, Excel, and clinical protocols.

Responsibilities

• Coordinate biospecimen data management.
• Maintain and improve BSO systems.
• Ensure GCP and GDPR compliance.
• Design collection plans.
• Oversee vendors.
• Mentor staff.
• Lead process improvements.

Skills

LIMS

Excel

Clinical protocols

Education

Bachelor's degree in life sciences

Job description

Role

Manage and oversee clinical biospecimen operations within Denali's Biorepository and Clinical Study Management teams, ensuring sample integrity, compliance, and efficient processes to support clinical research.

Responsibilities

• coordinate biospecimen data management
• maintain and improve BSO systems
• ensure GCP and GDPR compliance
• design collection plans
• oversee vendors
• mentor staff
• lead process improvements

Requirements

• Bachelor's degree in a related life sciences field
• minimum of 5 years' experience in translational medicine or clinical development
• proficiency with LIMS, Excel, and clinical protocols

High-Value

• biospecimen management in clinical trials
• GCP/GDPR compliance
• cross-functional collaboration
• process improvement
• biologics/biomarker programs
• early to late-stage clinical research

Work Setup

not specified; likely office-based with collaborative environment