Manager, Biosample Operations
Kura Oncology, Inc.
19 days ago
Remote friendly (Boston, MA)
United States
Operations
Essential Job Functions
The Manager, Biosample Operations plans, implements, manages and drives biological sample logistics within Kura Oncology Phase I-IV Clinical Trials within Clinical Operations, under the Head of Clinical Operations (or designee), collaborating with Clinical Trial Leaders and cross-functional teams.
- Advise on and deliver the biosample strategy within clinical program(s) in accordance with quality and ethical/regulatory standards (including ICH/GCP/GLP).
- Ensure standardization and harmonization of biosample activities across trials; oversee sample collection, processing, storage, and reconciliation to maximize accrual and quality.
- Review protocols, informed consents, lab documents, case report forms, and vendor scope of work for sample handling details.
- Ensure ethical use of biosamples collected in Kura trials.
- Plan, coordinate, and oversee all operational activities across the patient sample lifecycle (site collection, vendor shipment for testing/processing, analysis, and final disposition).
- Ensure project-level consistency across studies; primary point of contact for project/clinical/study teams; drive improvements in collection, processing, and data delivery.
- Track and report biosample management status/progress; resolve issues.
- Collaborate with internal and external teams; other duties as assigned.
Job Specifications
- Bachelor’s degree in science/healthcare field, nursing degree, or equivalent.
- 4–6 years clinical trial management experience (preferred).
- 2+ years hands-on clinical biosample project management (preferred).
- Understanding of drug development process; ability to manage cross-functional teams.
- Strong relationships with external partners/CROs/biosample vendors.
- In-depth working knowledge of GCP and ICH.
- Knowledge of regulations for clinical trial authorization and tissue storage/transfer.
- Project management, risk/issue identification and mitigation.
- Independent and collaborative in fast-paced matrix environment.
- Analytical problem-solving; excellent verbal/written communication.
- Planning/organization/time management; ability to prioritize multiple projects.
- Execute functional decisions; align with broader program activities.
- Travel domestically/internationally (~10%).
- IND/NDA experience; EU/Asia filing a plus.
- Proficiency with Microsoft Office.
The base range for this role at the Manager level is $150,000 - $178,000 per year.
The Manager, Biosample Operations plans, implements, manages and drives biological sample logistics within Kura Oncology Phase I-IV Clinical Trials within Clinical Operations, under the Head of Clinical Operations (or designee), collaborating with Clinical Trial Leaders and cross-functional teams.
- Advise on and deliver the biosample strategy within clinical program(s) in accordance with quality and ethical/regulatory standards (including ICH/GCP/GLP).
- Ensure standardization and harmonization of biosample activities across trials; oversee sample collection, processing, storage, and reconciliation to maximize accrual and quality.
- Review protocols, informed consents, lab documents, case report forms, and vendor scope of work for sample handling details.
- Ensure ethical use of biosamples collected in Kura trials.
- Plan, coordinate, and oversee all operational activities across the patient sample lifecycle (site collection, vendor shipment for testing/processing, analysis, and final disposition).
- Ensure project-level consistency across studies; primary point of contact for project/clinical/study teams; drive improvements in collection, processing, and data delivery.
- Track and report biosample management status/progress; resolve issues.
- Collaborate with internal and external teams; other duties as assigned.
Job Specifications
- Bachelor’s degree in science/healthcare field, nursing degree, or equivalent.
- 4–6 years clinical trial management experience (preferred).
- 2+ years hands-on clinical biosample project management (preferred).
- Understanding of drug development process; ability to manage cross-functional teams.
- Strong relationships with external partners/CROs/biosample vendors.
- In-depth working knowledge of GCP and ICH.
- Knowledge of regulations for clinical trial authorization and tissue storage/transfer.
- Project management, risk/issue identification and mitigation.
- Independent and collaborative in fast-paced matrix environment.
- Analytical problem-solving; excellent verbal/written communication.
- Planning/organization/time management; ability to prioritize multiple projects.
- Execute functional decisions; align with broader program activities.
- Travel domestically/internationally (~10%).
- IND/NDA experience; EU/Asia filing a plus.
- Proficiency with Microsoft Office.
The base range for this role at the Manager level is $150,000 - $178,000 per year.