About this role
Randstad professional logo Clinical Study Manager Koninklijke Philips N.V. - Eindhoven - Detachering - HBO - 40 uur - € 5.950 per maand - Bewaar vacature Yoep Vaesen consultant [email protected] 06-51219111 Yoep Vaesen avatar [email protected] 06-51219111 Looking to make a global impact on healthcare? As a Clinical Study Manager at Philips, you drive challenging clinical studies for innovative grooming and beauty products, elevating medical solutions to the highest standards of safety and quality. In this dynamic role within the Grooming & Beauty business, you ensure every clinical trial runs seamlessly according to international regulations. You collaborate closely with cross-functional teams and external study sites to bring innovative technologies safely to market. Your key responsibilities: • Lead and manage clinical studies in full compliance with ISO, GCP, and FDA guidelines. • Support and guide study sites and investigators on protocol requirements and regulatory expectations. • Review and verify project documentation for complete accuracy and regulatory compliance. • Monitor study progress, budgets, and schedules through proactive trend and risk analyses. • Act as a subject matter expert on clinical research across cross-functional teams. Functie-eisen You will be successful if: • You have at least 3 years of experience in the medical device or pharmaceutical industry. • You have demonstrable knowledge of ISO, ICH-GCP, and FDA regulations. • You have experience working with digital systems such as EDC, eTMF, and CTMS. • You hold a bachelor's or master's degree in a relevant scientific or medical field. Competenties Effective Communication: You align efficiently with cross-functional stakeholders including R&D, Regulatory Affairs, and Marketing. • Analytical Thinking: You identify data deviations quickly and translate trends into concrete action plans and risk mi...