eGenesis, Inc.

Clinical Research

• Manage all aspects of clinical trials, including study vendor management, CRO oversight, timelines, and budgets
• Assist in preparation and review of clinical study documentation including, but not limited to, protocol, informed consent, Clinical Monitoring Plan, Project Plan, Case Report Forms, Clinical Study Reports, and other study level documents
• Engage cross-functionally to ensure clear, consistent communication to key stakeholders on study status, metrics and timelines
• Ensure implementation and conduct of study(ies) in accordance with SOPs and ICH-GCP guidelines
• Serve as point of contact for CRO and clinical site communication
• Set up the Trial Master File (TMF) and appropriately maintain the TMF throughout the trial, including periodic reviews
• Participate and coordinate resolution of audit findings and ensure audit-ready condition of clinical trial documentation including central clinical files
• Proactively identify risks in study timelines in regard to key milestones and deliverables and work closely with the cross-functional teams to mitigate downstream impacts

Senior Clinical Trial Manager