Clinical Study Manager
Netherlands, North Brabant, Eindhoven
Fulltime: 40 hrs a week / € 4800 - 5800 per month
Experience: From 2 years
Medical devices
Introduction
As a Clinical Study Manager, you are responsible for planning, coordinating, and overseeing clinical studies for Philips' Grooming & Beauty business, ensuring all research is conducted in accordance with Good Clinical Practice (GCP), ISO standards, FDA regulations, and Philips procedures.
What are you going to do
- Lead the end-to-end management of clinical studies, from study planning to close-out.
- Ensure compliance with regulatory requirements through site monitoring, training, audits, and data verification.
- Collaborate with investigators and study sites, providing guidance on protocols and regulatory expectations.
- Act as the clinical and regulatory expert on GCP, ISO, and FDA requirements for medical device studies.
- Review study documentation, monitor data quality, resolve study issues, and ensure accurate reporting.
- Develop study protocols and optimize clinical research processes to improve efficiency and data quality.
- Manage timelines, budgets, risks, and study progress, proactively addressing deviations.
- Work closely with cross-functional teams including Regulatory Affairs, R&D, Quality, Marketing, Biostatistics, Data Management, Clinical Development, and Health Economics & Market Access (HEMAR).
- Use clinical trial systems such as EDC, eTMF, and CTMS to manage study execution.
Essential skills and knowledge
- At least 3 years of experience in the medical device, pharmaceutical, or another regulated industry.
- Experience managing clinical studies for medical devices is strongly preferred.
- Strong knowledge of the clinical research process, ICH-GCP guidelines, and applicable regulatory requirements.
- Experience within the cosmetics industry is considered a strong advantage because you will be working Philips Lumea IPL
What we offer
- A gross monthly salary between €4,800 and €6,000 (excluding 8% holiday allowance), depending on experience.
- 26 vacation days, with the option to extend.
- Flexible working hours and hybrid working possibilities.
- Extensive training and career development opportunities, including access to the Brunel Academy.
- A solid pension scheme and collective health insurance.
- Access to vitality programs and gym discounts.
About Brunel
Brunel Engineering specializes in connecting highly skilled professionals to challenging projects within technical and life sciences environments.
Brunel offers outstanding individuals a diverse and challenging career within a company that values an open, professional, and collaborative culture. Personal initiative is recognized and rewarded, and you will receive the support, coaching, and training needed for your future career. This is your opportunity to explore a wide range of industries and further develop your expertise in a fast-paced and results-driven environment.
Working via Brunel means stability and growth: you not only receive a contract but also build a strong foundation for a successful career.