Manager, Biosample Operations

Daiichi Sankyo

Full-time - Mid Level

10,001+ employees

Health and Personal Care Retailers

About the position

The Biosample Operations Manager is responsible for overseeing the lifecycle of biosamples in clinical trials, ensuring proper tracking, collection, storage, and disposal in accordance with study protocols. This role involves collaboration with various internal and external stakeholders to manage biosample activities effectively from study start-up to close-out.

Responsibilities

• Perform near real-time biosample tracking for assigned studies in collaboration with various teams.
• Oversee CRO partner sample management activities including tracking and query resolution.
• Support planning and coordination of biosample lifecycle activities such as collection and analysis.
• Implement and maintain tracking tools for biosample management.
• Manage biosample shipments and reconcile shipment manifests.
• Review CRO partner Sample Management Plans for cross-functional agreements.
• Provide updates and coordinate sample movements for analysis or storage.
• Support inventory reviews and obtain approvals for sample disposal or transfer.
• Resolve biosample-related data reconciliation and issues in collaboration with stakeholders.
• Support clinical study teams with sample-related questions and escalations.
• Review study documents related to biosample handling and storage.
• Participate in CRF development for sample tracking purposes.
• Support resolution of informed consent and IRB/EC questions regarding biosamples.
• Develop and update global policies and SOPs for biosample management activities.
• Establish performance and quality targets for biosample vendors.
• Identify trends in biosample queries and implement improvements.
• Conduct gap assessments and develop project plans for process revisions.

Requirements

• Bachelor's degree in Life Sciences field required.
• Minimum of 4 years relevant experience required.
• 2 or more years of biosample handling experience required.
• Working knowledge of ICH/GCP and regulatory guidelines preferred.
• Working knowledge of CLIA/CAP regulations and GLP guidelines preferred.
• Basic knowledge of clinical trial design and drug development process preferred.
• Excellent organizational and communication skills required.
• Advanced Excel knowledge preferred.
• Ability to manage multiple competing priorities and meet timelines required.
• Proven networking skills and ability to share knowledge preferred.