In this role, you have the opportunity to Impact through the development and testing of quality Philips products and solutions that help countless people worldwide
Functie-eisen
- Lead the end-to-end management of clinical studies in strict compliance with ISO, GCP, FDA, and internal Philips procedures.
- Execute meticulous site assessments, remote and on-site monitoring, and close-out visits to ensure data accuracy and study integrity.
- Act as a Subject Matter Expert (SME) on regulatory requirements for human subject research within the medical device industry.
- Collaborate with investigators and study sites to provide expert guidance on protocol requirements and regulatory expectations.
- Review project documentation and deliverables for completeness, accuracy, and adherence to GCP guidelines.
- Optimize clinical research lifecycles by enhancing study procedures to improve operational efficiency and data quality.
- Partner cross-functionally with R&D, Regulatory, Quality, Biostatistics, and Clinical Development to align on project objectives.
- Develop robust study plans and protocols that integrate regulatory standards with core business goals.
- Manage study progress by analyzing trends and deviations to inform risk mitigation strategies and budget oversight.
- Utilize clinical trial applications (EDC, eTMF, and CTMS) to maintain high-level data management and reporting.
Competenties
- Experience: Minimum 5 years in a regulated environment (Medical Device or Pharmaceutical), with a strong preference for medical device clinical study experience.
- Regulatory Knowledge: Profound understanding of clinical research legislation, ICH-GCP guidelines, and FDA/ISO standards.
- Technical Proficiency: Advanced skills in Electronic Data Capture (EDC), Clinical Trial Management Systems (CTMS), and Document Auditing.
- Project Leadership: Proven ability to manage complex budgets, schedules, and cross-functional stakeholder relationships.
- Analytical Rigor: Strong capability in data analysis, interpretation, and the resolution of complex study discrepancies.
- Communication: Exceptional ability to foster collaboration with external investigators and internal leadership teams.
- Quality Focus: High attention to detail in document management, reporting, and maintaining the highest standards of clinical research.
Arbeidsvoorwaarden
- Salary: Best in the market.
- Holiday Allowance – 8% of your annual salary, ensuring you can fully enjoy your time off.
- Pension Plus Scheme – Secure your future with our comprehensive retirement plan.
- Home Office Setup – Receive a €750 net allowance to create a comfortable and productive workspace.
- Time to Recharge – Enjoy 25 vacation days per year (based on a 40-hour workweek).
- Travel Allowance – Support for commuting expenses.
- Internet Allowance – Contribute to seamless remote work.
- Relocation Assistance – Moving to the Netherlands? We’ve got you covered.
Bedrijfsinformatie
You are a part of Building up the clinical expertise within Philips. You will serve the Grooming & Beauty Business in Philips. You will work closely together with several teams including Regulatory, Marketing, and Product Development.
Uiteraard staat deze vacature open voor iedereen die zich hierin herkent.
contact
Amisha Kashyap
amisha.kashyap@randstadprofessional.nl
+918374294984
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