ICBE Monitoring Specialist
Adding an ICBE monitor / secretary resource to address high workload of current ICBE monitor/secretary team.
Key Areas of Responsibility (KARs)
• Monitor clinical studies involving medical/non-medical devices at clinical sites according to Good Clinical Practices for Medical Devices (ISO14155).
• Support, update and maintain the Clinical Trial Management System application for clinical study execution and reporting.
• Facilitate reviews by internal privacy, legal, regulatory affairs, risk management and ethics domain experts for al study protocols as Secretary of the CTO Internal Review Committee [also known as the Internal Committee for Biomedical Experiments (ICBE)]. This includes a Secretary pre-review step.
• Participate in the development and maintenance of process documents, templates, guidelines, training material, FAQs and IT tools (e.g. ORION-ICBE and CTMS) linked to the CTO research review structure.
• Schedule and manage meetings as Secretary of the CTO Internal Review Committee.
Minimum Required Competencies
• Bachelors degree in life sciences or related medical/scientific field.
• Clinical Research Associate (RCA) certification.
• 3+ years experience in monitoring clinical studies including qualification, initiation, interim, and close-out monitoring activities.
• Demonstrated knowledge of Good Clinical Practice (GCP) and FDA(USA) regulatory requirements for the conduct of research involving human subjects.
• Experience in conducting Clinical Trials utilizing Electronic Data Capture platform.
• Must be willing to travel in Europe for monitoring activities.
• Experience in working with the following software tools: MS Word, MS Excel, MS PowerPoint.
• Fluent in English (verbal and written, especially scientific writing).
• Demonstrated ability to work effectively in cross-functional and geographically diverse teams, including the ability to plan and facilitate face-to-face and digital meetings.
Additional Preferred Competencies
• Experience in the medical device industry and testing products in related fields
• Experience in lean and agile ways of working.
• Ability to work in high pressure contexts requiring multi-tasking.
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.