Project Manager

• Lead and oversee clinical project management activities for multiple studies, ensuring adherence to timelines, budgets, and quality standards.
• Manage and mentor Clinical Project Managers and support staff, fostering a culture of accountability and continuous improvement.
• Champion process improvement initiatives to optimize workflows, establish best practices, and ensure consistent, efficient project management across all clinical studies.
• Develop and implement project plans, risk mitigation strategies, and contingency plans.
• Serve as the primary liaison between Clinical Affairs and cross-functional teams (Medical Affairs, R&D, Regulatory, Quality, Legal, and Operations).
• Oversee vendor selection, contract negotiations, and performance management for CROs and other external partners.
• Ensure compliance with applicable regulatory requirements, including GCP, ISO 14155, and FDA guidelines.
• Monitor study progress, resolve complex issues, and escalate as needed to senior leadership.
• Contribute to protocol development, IDE submissions, and interactions with regulatory authorities.
• Prepare and present project status reports and key performance metrics to stakeholders.

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