Clinical Biomarker Operations Program Manager - Shanghai
行业&领域: 健康 医疗服务或保障, 项目管理/运营/交付
Summary
The Program Manager, supporting Clinical Biomarker Operations, will be a centralized point of contact to implement and communicate project needs, processes, and standard practices for all assigned studies and projects for one of our sponsors. This role is under our Functional Service Provider (FSP) Solutions Division. They will work cross-functionally to support multiple stakeholders including labs, therapeutic units, Clinical Operations, Procurement, R&D, IT, and Quality. Will be responsible for independent management of assigned studies, and will provide project management and operational oversight to support clinical biomarker operations and logistics with external venders, contributing to the provision of high-quality translational biomarker data. This position is located in Shanghai, China.
Responsibilities:
Responsible for forging and managing strong relationships with multiple CRO biomarker testing labs and bioassay vendors, biomarker specimen management and tracking, ensuring timely clinical sample testing and biomarker data management for studies solely or partly run in China.
Functions as key point of contact with external laboratories based in China, with oversight responsibilities for the development and finalization of agreements, statements of work, sample analyses, data transfer specifications and data transfer agreements.
Coordinates and delivers the biomarker specimen strategy within multiple clinical programs in accordance with the requirements of quality, and ethical and regulatory standards, including ICH/GDPR/GCP/GLP
Collaborate with study teams, Clinical Biomarker and Global Translational Leads to develop Clinical Sample Management Plans.
Accountable for planning and coordinating the process of drafting the Clinical Sample Management Plans at external stakeholders, as well as initiating the amendment process if biomarker specimen collection, handling and processing steps are impacted by study protocol amendments for samples applicable to China only or global protocols with a Chinese component.
Review and provide input into clinical study protocols, informed consents, central laboratory and CRO study storyboard documents to ensure quality and accuracy with an eye toward HGRAC requirements.
Ensure biomarker specimen handling and processing steps are appropriately described in the Clinical Lab Manuals for collection, processing, and shipping of patient samples.
Accountable for thorough revision of biomarker specimen handling and processing steps within central lab documents upon study protocol amendments.
Ensures standardization and harmonization of end-to-end biospecimen activities across clinical trials; maximizing biomarker specimen accrual and quality
Accountable for planning, coordinating, and overseeing all operational activities required to manage the lifecycle of biomarker specimens (oversight of sample collection at site, shipment to vendor for testing/processing, analysis, reconciliation and final sample disposition).
Identifies stakeholders for questions impacting clinical samples and escalates issues to ensure a timely resolution
Addresses questions from the CRO or the third-party vendors as it relates to sample collections and/or queries
Oversees finalization of data transfer agreements (DTA) and ensures that data is transferred between bioassay vendors and CRO/sponsor to meet clinical trial and translational timelines.
Accountable for providing timely updates to the team during internal meetings as well as coordinate discussion and follow-up of deliverables that need to be prioritized according to study timeline.
Accountable for reviewing study meeting minutes and proactively following-up with internal/external stakeholders on biomarker related action items.
Education/Experience/Skills Required:
BA/BS or equivalent in life sciences, medical technology or related field, required.
3-5 years of experience in clinical development, biospecimen lifecycle management or clinical laboratory analysis, including a strong understanding of clinical research and the clinical trial process, required.
Fluent in both English and Mandarin, required including effective oral and written communication skills and technical writing.
Working Knowledge of ICH, GDPR, GCP, GLP and local regulatory is required.
Strong operational and demonstrated project management skills including timeline management, forecasting, and project management tracking.
Advanced planning, organizational, time management skills with a high level of attention to detail, required.
Strong computer literacy of MS Office Suite including Word, Excel, Smartsheet, SharePoint, PowerPoint. Project Management software is preferred.
Ability to build and maintain strong relationships with external vendors, partners, collaborators, and stakeholders.
Ability to work effectively in a matrix environment.
Ability to work independently, prioritize tasks, and mentor/lead others.
Working Location/Hours:
Must be local and eligible to work in Shanghai, China
100% remote, with the ability to be in office for occasional client meetings
LabConnect is the world’s most agile central laboratory solutions partner, providing technology-driven, customized, orchestrated, and scalable support services for clinical trials of all sizes and complexity. With 20+ years of experience and 2,000+ clinical studies across 93 countries, LabConnect is the trusted partner for biotechnology, pharmaceutical, and clinical research organizations.
With modern operations and strategic alliances with world-leading laboratories, LabConnect is uniquely positioned to provide access to the latest innovation and automation. LabConnect delivers exceptional service with a comprehensive suite of central laboratory solutions including custom lab kits, advanced sample tracking and integrated logistics, global standardized sample processing, industry-leading testing menu of 20,000+ validated assays, worldwide support for radiopharmaceuticals, and next-generation biorepository.
LabConnect scientific experts support pre-clinical and clinical studies with scientific project management, bioanalytical and biospecimen management, biomarker strategy and logistics solutions. LabConnect excels at data management, integrating complex datasets from diverse sources into a single, cohesive, submission-ready dataset.
For more information, visit www.labconnect.com
Website
https://www.labconnect.com/
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