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Clinical trial data coordinator
1 month ago
EXPERIENCE CLINICAL PROJECT ASSOCIATE II—BIOMARKER & BIOANALYTICAL OPERATIONS,
Duration: 18 months
- Supports the worldwide execution (start-up, maintenance, and close-out) of all Phase I - IV clinical trials.
- Working to ensure all Gilead 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 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.
- Arrange meeting logistics, and agendas, and assist with minutes.
- Assists with the development of documents and standard forms.
- Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.
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