Clinical Operations

• Builds and sustains long-lasting relationships with existing and potential clients (sponsors and CROs)
• Builds and sustains long-lasting relationships with Investigators and Medical Institutions representatives
• Assesses feasibility of research protocols based on knowledge and experience
• Supervises the conduct of clinical trials in accordance with ICH GCP
• Monitors individual stages of budget negotiations and research timelines
• Set up meetings with Investigators, pharmaceutical and CRO companies' representatives

Operations Manager, Clinical Trials

• Responsible for performing activities in compliance with applicable Corporate and Clinical Operations Policies, Standard Operating Procedures and Work Instructions
• Assists Clinical Monitoring staff with site management activities, including serving as a Sponsor representative for sites on assigned studies, and communicating with sites to ensure compliance with protocol requirements, study procedures and relevant guidelines
• Creates and assists with maintenance of Trial Master File (TMF) and project files, including participation in file audits
• Prepares and maintains site manuals, reference tools and other documents
• Maintains, updates, and inputs clinical tracking information into databases
• Tracks incoming and outgoing clinical and regulatory documents and updates for investigator sites, studies, project team, or client
• Manages shared mailbox, processes site requests and routes correspondence appropriately
• Coordinates the ordering, packaging, shipping and tracking of site supplies and materials
• Assists with coordination of team meetings, attends meetings and prepares accurate meeting minutes and action items
• May handle receipt, tracking and disposition of Case Report Forms and Queries
• Maintains overall awareness in the field of clinical research by completing all necessary and assigned training

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Operations Manager, Clinical Trials

CTA, Clinical Operations Specialist