Senior Manager / Manager, Biosample

About the role

The Biosample Senior Manager will manage the biospecimen lifecycle for clinical programs through collaboration with Clinical Operations, Data Management, Clinical Outsourcing, Translational Medicine, Pharmacology scientists, and external vendors that support clinical studies. Location: South San Francisco, CA - Remote Role.

Responsibilities

• Development of biospecimen lifecycle strategies through close collaboration with project teams and scientists (for PK, ADA, PD/Biomarkers, and Safety)
• Ensure program-level consistency and cross-program standardization of biospecimen collection, processing, storage, and analysis.
• Contribute to the development of study protocols, ICFs, and other relevant study documents.
• Manage the creation of complex sample management plans and laboratory documents that ensure the proper collection and storage of samples at clinical sites and external vendors.
• Collaborate with Clinical Operations, Outsourcing, and Quality Assurance in the selection and oversight of central laboratories and specialty bioanalysis labs to ensure they meet study requirements and adhere to relevant compliance standards.
• Create systems and tools to manage sample analysis plans and enable study leads to deliver samples to appropriate analysis vendors on time.
• Facilitate external analysis vendor interactions with Data Management to ensure consistency in the transmission of sample metadata for accurate identification of analyzed samples.
• Lead process improvement projects and participate in cross-functional projects and working groups.

Requirements

• A bachelor's degree in Biochemistry, Chemistry, Biology, Immunology, Neuroscience, Medical Technology, or a related field is recommended.
• At least 7 years of experience.
• Entrepreneurial spirit with "can-do" attitude and commitment to work as part of a team.
• Seeks change & values innovation.
• Advanced planning and organization skills, and excellent analytical skills.
• Must qualify as a W2 candidate.
• Unable to sponsor candidates at this time.

Preferred Qualifications

• Ability to lead effectively in a cross-functional team matrix environment.
• Working knowledge of biosample management for clinical trials. Familiarity with relevant FDA & ICH/GCP regulations.
• Ability to review and interpret clinical research protocols.
• Technical know-how to create tools to solve operational challenges and improve workflows.
• Previous experience in people management.

Skills

• Biosample Management
• Biospecimen Lifecycle Management
• Clinical Trials
• Clinical Operations
• Sample Management Plans
• Biospecimen Collection
• Sample Processing
• Sample Storage
• Sample Analysis
• PK Samples
• ADA Samples
• PD/Biomarkers
• Safety Samples
• Central Laboratory Oversight
• Bioanalytical Laboratory Oversight
• Vendor Management
• Clinical Outsourcing
• Translational Medicine
• Clinical Pharmacology
• Data Management
• Study Protocols
• Informed Consent Forms (ICFs)
• Laboratory Documentation
• Sample Metadata
• Regulatory Compliance
• FDA Regulations
• ICH/GCP
• Cross-Functional Leadership
• Process Improvement
• Workflow Optimization
• Project Management
• Analytical Skills
• Planning & Organization
• People Management

Pay

$65 - $75 per hour