Project Managers – Future Roles

Role Overview

• Creates and maintains the Trial Master File Management (TMF) Plan
• Routinely reviews the TMF to ensure quality, completeness and inspection readiness
• Coordinates and monitors the activities associated with study deliverables across all applicable internal functional departments and vendors
• Assists with activities associated with interim analyses, database snapshots and locks, final CSR and study closure
• Assists with identification of and contracting with approved vendors, as necessary
• Provides vendor management, inclusive of ensuring key deliverables are met, potential scope creep is identified and change orders are developed, as necessary
• Assists with development and implementation of change orders
• Assists with resource management and team member transition by collaborating with appropriate Resource Managers and ensuring detailed Transition Plans are developed and implemented efficiently
• Develops contingency planning and risk mitigation strategies to ensure meeting or exceeding study milestones
• Creation and maintenance of metric reports, inclusive of data collection from multiple sources, for delivery to client or senior management
• Assists with overall financial performance of the study by interacting with internal functional departments or vendors to obtain required metrics for financial reporting
• Attends financial review meetings to assist with reconciliation and identification of budget overrun
• Reviews and approves invoices from sites or vendors and to the client
• Participates in representing the company to the client, ensuring satisfaction levels are met and statuses of deliverables are communicated effectively
• May participate in Customer proposal development
• In collaboration with the Project Team, will plan, coordinate and present at internal and external meetings
• Facilitates team training in accordance with protocol and/or project requirements, including therapeutic, protocol specific, and process training
• Develops knowledge of current therapeutic environment

Requirements

• Creates and maintains the Trial Master File Management (TMF) Plan
• Routinely reviews the TMF to ensure quality, completeness and inspection readiness
• Coordinates and monitors the activities associated with study deliverables across all applicable internal functional departments and vendors
• Assists with activities associated with interim analyses, database snapshots and locks, final CSR and study closure
• Assists with identification of and contracting with approved vendors, as necessary
• Provides vendor management, inclusive of ensuring key deliverables are met, potential scope creep is identified and change orders are developed, as necessary
• Assists with development and implementation of change orders
• Assists with resource management and team member transition by collaborating with appropriate Resource Managers and ensuring detailed Transition Plans are developed and implemented efficiently
• Develops contingency planning and risk mitigation strategies to ensure meeting or exceeding study milestones
• Creation and maintenance of metric reports, inclusive of data collection from multiple sources, for delivery to client or senior management
• Assists with overall financial performance of the study by interacting with internal functional departments or vendors to obtain required metrics for financial reporting
• Attends financial review meetings to assist with reconciliation and identification of budget overrun
• Reviews and approves invoices from sites or vendors and to the client
• Participates in representing the company to the client, ensuring satisfaction levels are met and statuses of deliverables are communicated effectively
• May participate in Customer proposal development
• In collaboration with the Project Team, will plan, coordinate and present at internal and external meetings
• Facilitates team training in accordance with protocol and/or project requirements, including therapeutic, protocol specific, and process training
• Develops knowledge of current therapeutic environment

Benefits

• supportive and engaged line management
• technical and therapeutic area training
• peer recognition and total rewards program