Senior Manager, Bio-Sample Operations
Insmed Incorporated
4 hours ago
Remote
United States
Operations
Senior Manager, Bio-Sample Operations
Responsibilities:
- Serve as operational lead for clinical sample integrity, managing the full lifecycle from collection to disposition.
- Provide strategic day-to-day oversight of central and specialty laboratories to ensure compliance with study protocols and Informed Consent Forms (ICFs) for safety and biomarker samples across a portfolio.
- Oversee vendor selection, management, and performance for central safety (and specialty) laboratories to ensure high-quality, on-time delivery.
- Provide technical and operational leadership for clinical study teams on laboratory oversight and bio-sample operations.
- Manage end-to-end bio-sample lifecycle (collection, logistics, processing, analysis, data cleaning, and final disposition), directly and/or through vendor oversight.
- Review critical study documents (ICFs, study protocols, and CRO Clinical Laboratory Specifications) to ensure feasibility and alignment with sample collection procedures.
- Act as the Translational Bioanalytical Science (TBAS) group central point of contact for operational issues; proactively address potential quality issues with biomarker sample processing and/or shipment.
- Partner with cross-functional teams (Clinical Trial Operations, Clinical Development, Bioanalytical Sciences) to resolve sample-related informed consent and ethical queries.
- Oversee end-to-end clinical sample logistics, including management, distribution, and tracking of lab kits and supplies to sites.
- Oversee chain-of-custody and sample accountability from collection through analysis and long-term storage, ensuring compliance with GxP and ICH/GCP guidelines.
- Support investigational sites with training on lab procedures, troubleshooting, and rapid escalation resolution.
- Resolve bio-sample data reconciliation issues in collaboration with Data Management and CRO partners.
- Contribute to CRF development to ensure accurate laboratory sample data collection, tracking, and reconciliation.
Qualifications:
- Bachelor’s degree.
- Minimum 6 years’ experience in a clinical research setting with a Sponsor/CRO company (required).
Required/Preferred Skills & Experience:
- Strong knowledge of the clinical research process and functional areas of clinical trials (required).
- Experience conducting clinical trials across multiple phases and therapeutic areas (preferred).
- Strong leadership and project management skills; flexibility and agility in a multi-functional, global matrix (required).
- Highly organized with strong attention to detail and commitment to clarity, accuracy, and conciseness (required).
- Ability to work in a team-based environment with a hands-on approach (required).
- Must demonstrate core corporate competencies: Collaboration, Accountability, Passion, Respect, and Integrity.
Work Setting:
- Fully remote; occasional travel for team meetings or events; minimal travel expected.
Responsibilities:
- Serve as operational lead for clinical sample integrity, managing the full lifecycle from collection to disposition.
- Provide strategic day-to-day oversight of central and specialty laboratories to ensure compliance with study protocols and Informed Consent Forms (ICFs) for safety and biomarker samples across a portfolio.
- Oversee vendor selection, management, and performance for central safety (and specialty) laboratories to ensure high-quality, on-time delivery.
- Provide technical and operational leadership for clinical study teams on laboratory oversight and bio-sample operations.
- Manage end-to-end bio-sample lifecycle (collection, logistics, processing, analysis, data cleaning, and final disposition), directly and/or through vendor oversight.
- Review critical study documents (ICFs, study protocols, and CRO Clinical Laboratory Specifications) to ensure feasibility and alignment with sample collection procedures.
- Act as the Translational Bioanalytical Science (TBAS) group central point of contact for operational issues; proactively address potential quality issues with biomarker sample processing and/or shipment.
- Partner with cross-functional teams (Clinical Trial Operations, Clinical Development, Bioanalytical Sciences) to resolve sample-related informed consent and ethical queries.
- Oversee end-to-end clinical sample logistics, including management, distribution, and tracking of lab kits and supplies to sites.
- Oversee chain-of-custody and sample accountability from collection through analysis and long-term storage, ensuring compliance with GxP and ICH/GCP guidelines.
- Support investigational sites with training on lab procedures, troubleshooting, and rapid escalation resolution.
- Resolve bio-sample data reconciliation issues in collaboration with Data Management and CRO partners.
- Contribute to CRF development to ensure accurate laboratory sample data collection, tracking, and reconciliation.
Qualifications:
- Bachelor’s degree.
- Minimum 6 years’ experience in a clinical research setting with a Sponsor/CRO company (required).
Required/Preferred Skills & Experience:
- Strong knowledge of the clinical research process and functional areas of clinical trials (required).
- Experience conducting clinical trials across multiple phases and therapeutic areas (preferred).
- Strong leadership and project management skills; flexibility and agility in a multi-functional, global matrix (required).
- Highly organized with strong attention to detail and commitment to clarity, accuracy, and conciseness (required).
- Ability to work in a team-based environment with a hands-on approach (required).
- Must demonstrate core corporate competencies: Collaboration, Accountability, Passion, Respect, and Integrity.
Work Setting:
- Fully remote; occasional travel for team meetings or events; minimal travel expected.