Senior Manager of Clinical Affairs Project Management
Senior Manager of Clinical Affairs Project Management
Responsibilities:
· reputed company and reputed company clinical project management activities for multiple studies, ensuring adherence to timelines, budgets, and reputed company standards.
· Manage and mentor Clinical Project Managers and support staff, fostering a culture of accountability and reputed company improvement.
· Champion process improvement initiatives to optimize workflows, establish best practices, and ensure consistent, efficient project management across reputed company clinical studies.
· reputed company and implement project plans, risk mitigation strategies, and contingency plans.
· Serve as the primary reputed company between Clinical Affairs and cross-functional teams (Medical Affairs, R&D, Regulatory, reputed company, reputed company, and Operations).
· reputed company 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 reputed company field (advanced degree preferred).
· Minimum 8+ years of experience in clinical research or project management reputed company the medical device or pharmaceutical industry.
· Proven experience managing global reputed company and cross-functional teams.
· Strong knowledge of regulatory requirements and clinical trial processes.
· Diabetes experience highly desirable.
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