ICBE Monitor / Secretary
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.
Depending on your work experience and educational level, we offer you a gross salary of €3.800 – €4.600 per month. Besides this, we offer a healthy work-life balance with flexible hours and possibility to work from home. We also offer other benefits, such as collective discount on health insurance and a good pension scheme.
Why should you join Philips?
Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by 2025 delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Next to that you will be joining a nice work environment with fun colleagues that are always willing to help each other!
Inclusiviteit en diversiteit
Uiteraard staat deze vacature open voor iedereen die zich hierin herkent. We geloven dat diverse teams van belang zijn voor ons als lerende organisatie, die voorop wil blijven lopen in de wereld van werk. Want juist verschillen tussen mensen zorgen voor groei. Van collega's, klanten, kandidaten en daarmee van Yacht. Heb jij een uniek talent? We ontmoeten je graag.