Project Manager Remote

Introduction:

This position is for a Project Manager who will be responsible for leading the end-to-end implementation of clinical systems, including EDC, eTMF, CTMS, ePRO/eCOA, and eConsent platforms. The Project Manager will work closely with various teams to define business requirements, manage project planning, and ensure successful deployment of clinical trial management systems.

Responsibilities:

• Lead end-to-end implementation of clinical systems, including EDC, eTMF, CTMS, ePRO/eCOA, and eConsent platforms.
• Manage project planning, timelines, budgets, risks, dependencies, and stakeholder communications.
• Partner with Clinical Operations, Data Management, Regulatory, and IT teams to define business requirements and implementation strategies.
• Support or lead RFP processes, including vendor evaluation, product selection, and implementation planning.
• Coordinate with software vendors, system integrators, and cross-functional teams to ensure successful deployment.
• Oversee system configuration, data migration, integrations, testing, training, and go-live activities.
• Establish governance frameworks and ensure compliance with GxP, FDA, and industry regulations.
• Drive change management and user adoption across clinical teams.
• Monitor project performance and provide regular status updates to leadership and key stakeholders.
• Identify and mitigate project risks and issues to ensure successful delivery.

Requirements:

Required Skills: Clinical Trial Management System, Regulatory Compliance, Stakeholder Communications, Data Management