Senior Manager of Clinical Affairs Project Management
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. Apply tot his job