Biosample Lifecycle Lead — Clinical Trials

Bayside Solutions; California (MO); On-site; USD 120,000 - 180,000; Full time

Job summary

Bayside Solutions, Inc. seeks a Biosample Senior Manager to oversee the biospecimen lifecycle for clinical programs, collaborating with Clinical Operations, Data Management, Outsourcing, Translational Medicine, Pharmacology, and external vendors.

Responsibilities include strategy development and cross-program standardization across collection, processing, storage, and analysis. The role requires leading cross-functional teams, ensuring regulatory compliance (FDA/ICH-GCP), and driving process

Qualifications

• Bachelor’s degree in Biochemistry, Chemistry, Biology, Immunology, Neuroscience, Medical Technology or related field and 7+ years of experience.
• Ability to lead cross-functional teams and manage biospecimen lifecycle programs.
• Strong knowledge of regulatory requirements (FDA, ICH/GCP) and study protocols.
• Analytical thinker with excellent planning and communication skills.

Responsibilities

• Develop biospecimen lifecycle strategies across PK, ADA, PD/Biomarkers, and Safety.
• Standardize biospecimen collection, processing, storage, and analysis across programs.
• Contribute to study protocols, ICFs, and related documents.
• Create complex sample management plans and ensure proper storage at sites and vendors.
• Oversee central labs and specialty bioanalysis labs to meet study requirements and compliance.
• Create tools to manage sample analysis plans and timelines for vendors.
• Coordinate with Data Management to align sample metadata transmission for accurate sample IDs.
• Lead cross-functional process improvement and participate in projects.

Skills

Biosample Management

Biospecimen Lifecycle

Clinical Trials

Cross-Functional Leadership

Sample Management Plans

Sample Collection

Sample Processing

Sample Storage

Sample Analysis

Vendor Management

Regulatory Compliance

FDA / ICH-GCP

Data Management

Project Management

Process Improvement

Analytical Skills

Planning & Organization

People Management

Education

Bachelor's degree in Biochemistry/Chemistry/Biology/Immunology/Neuroscience/Medical Technology or related field

Tools

Laboratory Oversight Tools

Job description

Bayside Solutions, Inc. seeks a Biosample Senior Manager to oversee the biospecimen lifecycle for clinical programs, collaborating with Clinical Operations, Data Management, Outsourcing, Translational Medicine, Pharmacology, and external vendors.

Responsibilities include strategy development and cross-program standardization across collection, processing, storage, and analysis. The role requires leading cross-functional teams, ensuring regulatory compliance (FDA/ICH-GCP), and driving process