ProTrials Research Inc.

Clinical Operations

• Lead all clinical study operations, providing strategic/tactical planning, organization, and direction of study project(s) including but not limited to the oversight of clinical project timelines, reports, budgets, monitoring, site and vendor management, clinical supplies, and data collection
• Facilitate and foster positive, productive, and timely communication between sponsor, study team, and other functional groups
• Manage and motivate study team while serving as a mentor; mentorship may include identifying skills of the clinical team members and assisting with further professional development
• Provide proper financial oversight of study budget, including out of scope tracking, in conjunction with the Client Manager (CM) and ProTrials Finance Department
• Collaborate with senior management to provide study updates/progress, resourcing needs, sponsor issues, and health status at regularly scheduled intervals
• Drive the development, maintenance, and distribution of project plans based on project-specific requirements, throughout the life of the study (i.e., monitoring plan, communication plan, project management plan, eTMF plan, other plans as applicable)
• Manage studies in compliance with GCP, relevant SOPs, regulatory requirements, and project-specific plans
• Assess resourcing needs to ensure the study has the appropriate resources for the duration of the project
• Actively manage and track study risks (with team and sponsor input for potential obstacles that would delay the project’s progress while appropriately escalating issues
• Assess training needs of team members on the therapeutic area, protocol, special procedures/skills, and implement the appropriate training plans
• Delegate study team responsibilities and ensure that team members have the necessary tools and resources to effectively perform their role
• Monitor and manage the project’s progress and develop timelines with input from relevant stakeholders and sponsor approval; re-assess critical path for study progress and adjust timelines as needed
• Oversee activities and deliverables of outside vendors, as requested; ensure communication occurs between outside vendors, the team, and sponsor

Clinical Project Manager