Clinical Operations

• Lead and coordinate complex clinical projects across pharmaceutical, biotechnology, medical device, and consumer health clients
• Manage project-specific Sponsor services, including central lab exams, drug shipments, and document shipments
• Coordinate Sponsors, Investigators, and project team members
• Manage study data documentation, including CRFs, patient diaries, questionnaires, queries, study supplies, regulatory documents, and correspondence
• Ensure project timelines and budgets are maintained
• Monitor workload and performance of the project team
• Plan and monitor team tasks
• Coordinate Clinical Research Associate and Clinical Monitor activities
• Collaborate on local authority approvals, biometrics, safety, regulatory, and archiving activities
• Assist the Medical Monitor with protocols, Case Report Forms, and final Clinical Study Reports
• Deliver project-specific training and organize Monitor, Investigator, and project update meetings
• Provide project updates to Sponsors, Senior Project Managers, and Project Directors/Leaders
• Escalate issues to the Project Director/Leader
• Perform co-monitoring visits as necessary
• Tutor Project Coordinators and Project Manager I
• Maintain Sponsor relationships
• Prepare SOPs for clinical research activities and enforce Company procedures

Explore Senior Clinical Project Manager at ClinChoice. Review requirements and application details.