Senior Manager / Manager, Biosample

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

Job Summary:

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.

Duties and 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 and Qualifications:

• A bachelor's degree in Biochemistry, Chemistry, Biology, Immunology, Neuroscience, Medical Technology, or a related field is recommended, plus 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

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

Desired Skills and Experience

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

Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.

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