Clinical Study - Koninklijke Philips N.V.

• Participates in the handling of clinical studies, in compliance to all applicable regulations (like ISO, GCP and FDA) and Philips procedures, working under limited supervision.
• Ensures strict adherence to study protocols, regulatory standards, and Philips Processes/Procedures through meticulous execution of site assessment, on site and remote monitoring and training, and close-out visits, proactively addressing deviations and ensuring data accuracy and study integrity.
• Works with study sites and investigators to provide support and guidance on protocol requirements, study procedures, and regulatory expectations.
• Acts as a subject matter expert to provide guidance on GCP, ISO and FDA regulatory requirements for the conduct of research involving human subjects is required in the medical device industry.
• Helps to review project documentation and deliverables for accuracy, completeness, and compliance with established protocols and regulatory requirements, and GCP guidelines.
• Enhances study procedures and processes to optimize efficiency and data quality throughout the clinical research lifecycle and performs data review and verification activities to ensure accuracy and consistency of clinical trial data.
• Nurtures and maintains relationships within the Clinical and Medical functions, as well as cross-functionally with Clinical Development, Biostatistics and Data Managements, Regulatory, R&D, Quality and HEMAR and other internal partners to achieve project objectives.
• Tracks study progress and performance against milestones, timelines, and budgetary constraints, conducting in-depth analysis of trends and deviations to inform proactive decision-making, risk mitigation strategies, and continuous improvement initiatives.
• Resolves queries, issues, and discrepancies related to study conduct, data collection, and regulatory compliance in a timely and effective manner.

With a growing presence in cardiology, oncology, and women's health, Philips operates in the areas of Imaging Systems, Patient Care & Clinical Informatics, Home Healthcare and Customer Services. Philips combines its clinical expertise and human insights to create innovative solutions across the continuum of care, in partnership with clinicians and our customers, to provide better value and expand access to care for millions. Our teams are working hard every day to improve patient outcomes all the way from disease prevention and screening to diagnosis, treatment, therapy monitoring, and disease management. Irrespective of whether the care cycle takes the patient from doctor's office to hospital or hospital to home, or simply from one medical department to another, Philips Healthcare's unique medical solutions are designed to optimize the quality and flow of patient information and clinical decision making.

Good working conditions.

• Minimum 3 years of experience in Medical device, pharmaceutical industry, or other regulated environment experience is required, with medical device clinical study experience high preferred.
• Profound knowledge of clinical research process legislation and ICH-GCP guidelines.