Senior Manager Clinical Development overseeing clinical programs and leading cross-functional teams at Philips. Managing day-to-day operations in Medical Device Clinical Research and regulatory compliance in EU and USA.
Responsibilities
Responsible for planning, direction, and coordination of clinical programs and activities, including overseeing Clinical Evidence planning and generation, Clinical PIL tools, process implementation, ensuring compliance with applicable laws, regulations, and standards.
Ensures accountability for process execution, system functionality, backlog management, and improvement initiatives.
Assists in the updates and enhancement of quality system processes for Clinical & Medical Affairs, aligning with business strategies, roadmaps, and Informatics demands.
Serves as a primary point of contact between Clinical & Medical Affairs and other departments, driving cross-function cooperation and ensuring stakeholder alignment.
Coordinates change requests and submissions, ensuring all critical parties are aligned and changes are effectively implemented.
Works with a diverse global team, emphasizing project management, business analysis, service management, solution ownership, and validation to achieve targeted outcomes.
Promotes application standardization through shared processes, data harmonization, and architectural compliance while fostering strong relationships.
Leverages expertise in Clinical & Medical Affairs to propose innovative ideas that support the function meeting their objectives.
Ensures compliance with training requirements and driving continuous improvement for the clinical programs.
Supports the development of the Clinical & Medical Affairs team by sharing resources, knowledge, and experience, and leading initiatives that enhance the organization.
Requirements
You have a minimum of 10+ years’ combined experience in Medical Device Clinical Research and Medical Device development within FDA regulated OEM product environments.
Proven experience in clinical validation, measurement, sustaining, as well as design, execution and oversight of clinical research, planning and associated technologies/tools.
Experience in Patient Monitoring (desired).
You have a minimum of 3+ years’ experience in Project/Program management and/or Team leadership, with proven experience in budgeting, training, staff development, resource allocation, continuous improvement, etc.
You have a detailed understanding of Clinical & Medical Affairs, leveraging expertise to propose innovative ideas, providing meaningful input and contribute to senior leadership discussions.
You have a deep understanding of Health Care Research methodology, regulations, laws, and guidance in major markets such as EU, USA, UK, AUS, Japan and China.
Proven experience in building/Cultivating strong working relationships and partnerships with business stakeholders/functions and influencing internal/external service providers towards achieving strategic objectives.
You have a minimum of a Bachelors’ Degree (Required) in Biology, Health Science MPH, Nursing or equivalent.
Master’s/PhD desired.
Six Sigma, Safe, Agile, PMP certifications desired.
Benefits
Paid time off
Professional development opportunities
Job title
Senior Manager Clinical Development – Patient Monitoring
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