Bioanalytical External Study Monitor
- Shanghai, China
Site Name: China - Beijing - ChaoYang District - Ocean International Centre - Tower A, China - Shanghai - PuDong New District - Lane 999 Huanke Road - Building18
Posted Date: Oct 15 2020
Primary Responsibilities and Accountabilities
- Act as the primary interface for communications between GSK (BIB analysts, Clinical Pharmacology, Modelling and Simulations, Clinical study team, Data Management, Statistics) and CRO staff based in China.
- Manage the CRO vendor network in China to transfer and deliver relevant bioanalytical assays to support clinical biopharmaceutical and small molecule programs including selection, Confidentiality disclosure agreements (CDAs), service agreements, contract negotiation, protocols, study reports with selected CROs
- Provide budget forecasting for GSK clinical validations and sample analysis to Clinical study team and provide updates following study refinement and amendments
- Review documents/sections pertaining to sample analysis and collection (SPMs, relevant protocol sections, central lab worksheets)
- Work closely with CRO partners for all study specific logistics including shipments, sample reconciliation and randomization and ensure timelines are met for method development and sample analysis are met and communicate any delays.
- Shipment and supply of reference material and custom reagents working with relevant GSK and CROs departments
- Review of validation and sample analysis plans/reports including stability assessment, co-meds, cross-validation) and sample analysis condition/timing.
- Review of data from method development, validation and sample analysis including transfer via relevant systems
- Evaluate CRO compliance with GLP, GCP and GcLP as appropriate, and worldwide regulations, relevant SOPs, protocols, policies and procedures, in partnership with GSK external Lab QA and Procurement Organisation
- Collaborate with TPR, BIB analyst and relevant disciplines in GSK and CROs to manage and resolve scientific, technical or quality issues and improve study consistency, quality, efficiency and effectiveness
- Work with clinical study team on the development of documents associated with GSK processes or regulatory requirements (CSRs, NMPA filing documents). Scientific input may be required for translation needs
- Support clinical study team for NMPA inspections by addressing scientific questions where appropriate
- Keep up to date with new and emerging analytical technologies and CRO landscape to address these requirements
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