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Clinical Trial management system data coordinator
3 months ago
Title: Clinical Project Assistant – II (Biomarker and Bioanalytical OPS)
Location: Foster City, CA
Duration: 18 Months on W2
Supports in the worldwide execution (start-up, maintenance and close-out) of all Phase I - IV clinical trials across all therapeutic areas
• Working to ensure all clinical trials are performed in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely and high-quality clinical data, that supports global registration and commercialization of Client’s products.
• Using Power BI, Pivot Tables and Pivot Charts to create, maintain, and present, critical knowledge of Biomarker and Bioanalytical sample summaries for all active and closed Clinical Trials; to facilitate awareness, as well as quick and accurate decision making.
• Consistently communicates with outside vendors and cross functional departments to ensure timelines are met in a timely and accurate manner.
• Supports in the UAT and implementation of new clinical sample management software
• Took on the full re-organization, maintenance and department education on the group shared files (MS Teams, SharePoint, shared drives, etc.)
• Handles all department eTMF responsibilities.
• Tracks and prepares study-specific information using databases, spreadsheets, and other tools.
• Reviews and participates in the quality assurance of data or documents.
• Arranges meeting logistics, agendas, and assists with minutes.
• Assists with development of documents and standard forms.
• Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.
