Beschreibung

In this role, you will manage clinical programs and ensure compliance while fostering collaboration across departments. Your day-to-day responsibilities will involve coordinating activities, driving improvements, and supporting the development of the Clinical & Medical Affairs team.

Anforderungen

• •Minimum 10 years’ experience in Medical Device Clinical Research and development
• •Proven experience in clinical validation, measurement, and oversight of clinical research
• •Minimum 3 years’ experience in Project/Program management and/or Team leadership
• •Detailed understanding of Clinical & Medical Affairs
• •Deep understanding of Health Care Research methodology and regulations
• •Proven experience in building strong working relationships with stakeholders
• •Minimum Bachelor's Degree in Biology, Health Science, Nursing or equivalent
• •Ability to perform minimum Physical, Cognitive and Environmental job requirements

Aufgaben

• •Plan and coordinate clinical programs and activities
• •Oversee Clinical Evidence planning and generation
• •Implement Clinical PIL tools and processes
• •Ensure compliance with laws, regulations, and standards
• •Manage process execution and system functionality
• •Handle backlog management and improvement initiatives
• •Update and enhance quality system processes for Clinical & Medical Affairs
• •Align processes with business strategies and Informatics demands
• •Serve as the primary contact between Clinical & Medical Affairs and other departments
• •Drive cross-functional cooperation and stakeholder alignment
• •Coordinate change requests and submissions
• •Ensure alignment and effective implementation of changes
• •Work with a diverse global team on project management and business analysis
• •Promote application standardization and data harmonization
• •Foster strong relationships within the organization
• •Propose innovative ideas to support Clinical & Medical Affairs objectives
• •Ensure compliance with training requirements
• •Drive continuous improvement for clinical programs
• •Support team development by sharing resources and knowledge
• •Lead initiatives that enhance the organization

Tools & Technologien

Benefits