Job description
Join a Legacy of Innovation 110 Years and Counting!
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
Summary
The Manager, Bio-Sample Operations is responsible for supporting the oversight of the end-to-end lifecycle of biomarker samples in clinical trials including but not limited to near real-time tracking of samples, ensuring that samples are collected, used, stored or disposed of appropriately per the associated study Informed Consent Forms (ICFs). The role is expected to work in close collaboration with several cross-functional stakeholders including but not limited to Clinical Biomarker, Companion Diagnostics, and Clinical Study Teams.
Responsibilities
Responsibilities
Chain of Custody
- Responsible for performing near real-time biomarker specimen tracking for the assigned studies in close collaboration with the Clinical Biomarker Team, the Clinical Study Teams, and CROs.
- Lead the gathering, analyzing, and interpretation of reports from CRO partner, EDC databases, central lab databases, and specialty lab databases to align data into trackers. Oversee CRO partner sample management activities per study level including sample tracking, site escalations, query resolution, and lost samples.
- Support the planning and coordination of biosample activities required to manage the lifecycle of biospecimen samples (e.g., collection, shipping, processing, analysis, data delivery and cleaning, and final sample disposition).
- Support implementation, maintenance, and use of enterprise (e.g. GlobalCode), and other excel based sample tracking tools. Responsible for running the outputs as needed from the tools to support tracking.
- Review the CRO partner Sample Management Plan, to document cross-functional agreements on the tracking, lifecycle and reconciliation plan for each sample type.
- Responsible for providing timely updates and coordination of sample movements needed for analysis or long-term storage to key stakeholders including Clinical Biomarker Team, Companion Diagnostics Team and Clinical Operations.
- Support the management of the lifecycle of biomarker samples to ensure that samples are used and/or stored appropriately per the associated ICFs.
- Support ongoing inventory reviews and work with the appropriate stakeholders to obtain approvals for disposal/transfer of samples in long-term storage facilities.
- Support resolution of biosample related data reconciliation and sample related issues at sites or analysis labs in collaboration with relevant stakeholders including Data Management, Clinical Operations and Clinical Biomarker.
- Support clinical study teams and biomarker sub-teams on technical and operational sample-related questions and/or escalations. Triage requests to the appropriate SME and follow up on the requests/escalation as needed.
Process Documentation and Improvement
- Support review of study documents that pertain to bio-sample collection, handling, and storage including clinical study protocols, ICFs, and lab manuals.
- Participate in CRF development to ensure laboratory sample information is collected for sample tracking and reconciliation purposes.
- In collaboration with Clinical Biomarker Team, support review of contracts for vendors responsible for sample processing, PGx analysis, and storage Support resolution of informed consent and IRB/EC questions related to bio-samples in collaboration with Clinical Biomarker Team & Clinical Study Teams.
- Support development and update of global DS policies, guidance documents, SOPs, or SOIs to support bio-sample management activities.
- Ensure appropriate performance and quality targets are established (via metrics and KPIs) and oversight is maintained to understand target realization.
- Lead and/or support identification and implementation of improvements to the site contract and budget processes. Support activities include but are not limited to conduct of gap & impact assessment and developing project scope and project plans.
- Work cross-functionally with stakeholders to identify when a process revision is required.
People Management & Resource Planning
- Support development of a plan for resourcing of activities within remit/scope.
- Depending on business priorities, manage employee direct reports and associated employee development duties.
- Depending on business priorities, manage contractor-based staff in collaboration with DSI HR and vendor providers as appropriate.
Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education Qualifications: (from an accredited college or university)
- Bachelor's Degree in a Life Sciences field required.
Experience Qualifications
- Minimum of 4 years' experience in pharmaceutical or biotechnology drug development required.
- 2 or more years of bio-sample handling experience preferred.
- Working knowledge of ICH/GCP and regulatory guidelines/directives preferred.
- Working knowledge of CLIA/CAP regulations and GLP guidelines preferred.
- Basic knowledge of clinical trial design; understanding of the overall drug development process.
- Excellent organizational and communication skills.
- Advanced Excel knowledge preferred.
- Ability to manage multiple competing priorities and meet timelines.
- Proven networking skills and ability to share knowledge and experience amongst colleagues.
Travel
- Ability to travel up to 20% May require some travel (domestic or global)
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
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