Clinical Trial Manager, Biospecimen
Structure Therapeutics
15 days ago
Remote friendly (South San Francisco, CA)
United States
Clinical Research and Development
Position Summary
Clinical Trial Manager (CTM), Biospecimens Management (Clinical Operations). Operational lead for biospecimen strategy execution across global clinical trials; reports to the Head of Clinical Operations.
Job Responsibilities
- Lead operational implementation of biospecimen strategy across assigned clinical programs.
- Translate sample analysis plans into executable operational plans with Clinical Development and Translational teams.
- Ensure alignment between protocol requirements, laboratory manuals, and vendor capabilities.
- Oversee development/review of laboratory manuals, sample collection guidelines, and kit specifications.
- Ensure laboratory timelines align with clinical study timelines; identify risks and mitigate.
- Participate in RFI/RFP processes; evaluate proposals; negotiate scopes of work, budgets, and contracts.
- Provide day-to-day oversight of central/specialty labs, biomarker vendors, bioanalytical labs, and biobanking partners.
- Manage change orders, scope adjustments, and budget revisions; monitor vendor KPIs and resolve/escalate issues.
- Oversee global sample flow: collection, processing, shipment, tracking, reconciliation, analysis, and storage.
- Ensure sample tracking/reconciliation systems are accurate and audit-ready; support chain of custody and sample integrity.
- Support inspection readiness for laboratory and biospecimen management.
- Ensure compliance with ICH/GCP, regulatory requirements, and company SOPs; support SOP development.
- Maintain accurate documentation in eTMF/CTMS; support inspections/audits.
- Directly manage and develop junior Biospecimen Management team members.
Qualifications
- Bachelor’s degree or equivalent (scientific/healthcare preferred).
- 7+ years industry experience in clinical research, laboratory operations, or related roles (increasing responsibility).
- 3+ years study management or laboratory/vendor oversight in clinical drug development.
- Experience managing central/specialty labs or biomarker vendors in global, multicenter trials.
- Experience with biospecimen logistics, reconciliation, and sample lifecycle management.
- Experience managing vendor budgets and contracts.
- Global study experience (US, EU, and/or APAC preferred).
Core Skills/Knowledge
- Clinical trial processes and laboratory operations.
- FDA/EU/ICH-GCP regulations for biospecimen handling.
- Vendor management/negotiation; cross-functional leadership and communication.
- Detail-oriented; strong risk identification/mitigation.
- MS Office; EDC, CTMS, eTMF.
Travel Required: Up to 20%
Application Instructions
Apply through the official career page at BambooHR.
Clinical Trial Manager (CTM), Biospecimens Management (Clinical Operations). Operational lead for biospecimen strategy execution across global clinical trials; reports to the Head of Clinical Operations.
Job Responsibilities
- Lead operational implementation of biospecimen strategy across assigned clinical programs.
- Translate sample analysis plans into executable operational plans with Clinical Development and Translational teams.
- Ensure alignment between protocol requirements, laboratory manuals, and vendor capabilities.
- Oversee development/review of laboratory manuals, sample collection guidelines, and kit specifications.
- Ensure laboratory timelines align with clinical study timelines; identify risks and mitigate.
- Participate in RFI/RFP processes; evaluate proposals; negotiate scopes of work, budgets, and contracts.
- Provide day-to-day oversight of central/specialty labs, biomarker vendors, bioanalytical labs, and biobanking partners.
- Manage change orders, scope adjustments, and budget revisions; monitor vendor KPIs and resolve/escalate issues.
- Oversee global sample flow: collection, processing, shipment, tracking, reconciliation, analysis, and storage.
- Ensure sample tracking/reconciliation systems are accurate and audit-ready; support chain of custody and sample integrity.
- Support inspection readiness for laboratory and biospecimen management.
- Ensure compliance with ICH/GCP, regulatory requirements, and company SOPs; support SOP development.
- Maintain accurate documentation in eTMF/CTMS; support inspections/audits.
- Directly manage and develop junior Biospecimen Management team members.
Qualifications
- Bachelor’s degree or equivalent (scientific/healthcare preferred).
- 7+ years industry experience in clinical research, laboratory operations, or related roles (increasing responsibility).
- 3+ years study management or laboratory/vendor oversight in clinical drug development.
- Experience managing central/specialty labs or biomarker vendors in global, multicenter trials.
- Experience with biospecimen logistics, reconciliation, and sample lifecycle management.
- Experience managing vendor budgets and contracts.
- Global study experience (US, EU, and/or APAC preferred).
Core Skills/Knowledge
- Clinical trial processes and laboratory operations.
- FDA/EU/ICH-GCP regulations for biospecimen handling.
- Vendor management/negotiation; cross-functional leadership and communication.
- Detail-oriented; strong risk identification/mitigation.
- MS Office; EDC, CTMS, eTMF.
Travel Required: Up to 20%
Application Instructions
Apply through the official career page at BambooHR.