Senior Manager of Clinical Affairs Project Management

Responsibilities:

· 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.

Education and Experience:

· Bachelor’s degree in Life Sciences, Health Sciences, or related field (advanced degree preferred).

· Minimum 8+ years of experience in clinical research or project management within the medical device or pharmaceutical industry.

· Proven experience managing global clinical trials and cross-functional teams.

· Strong knowledge of regulatory requirements and clinical trial processes.

· Diabetes experience highly desirable.

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Senior Manager Clinical Affairs Project Management

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