Operations

• Oversee operational work related to rater selection, certification/qualification, training content, scale acquisition, surveillance maintenance, and workbook/source document management
• Ensure assigned projects are timely and compliant with SOPs, ICH/GCP, and regulatory guidelines
• Coordinate completeness of rater experience qualification documents and communicate results to Sponsors and study teams
• Develop study-specific rater training web portals and ensure readiness to study timelines
• Coordinate Investigators’ Meetings and associated CAT materials
• Organize editing and formatting of didactic training presentations
• Oversee scale and study source workbook management, including licenses, translations, regulatory authorizations, and Sponsor approvals
• Maintain data surveillance methodology by tracking and reconciling source documentation and providing reports
• Provide CAT data for Final Study Reports
• Oversee archiving of CAT study documents
• Consult on rater training and data surveillance plans
• Develop and present at Sponsor Kick-Off Meetings regarding CAT operations
• Work with the Operations Director and study team to meet budgetary demands
• Manage assigned Operations staff
• Perform other duties as assigned

Operations jobs in Samoa

Manager, Clinical Assessment Technologies Operations