As a Clinical Study Lead, you will be responsible for the end-to-end management of clinical studies, ensuring compliance with all applicable regulations including ISO, GCP, and FDA standards, as well as internal Philips procedures. You will play a critical role in ensuring the integrity, accuracy, and quality of clinical data while fostering collaboration across internal and external stakeholders.
Key Responsibilities:
- Clinical Study Management: Lead the planning, execution, monitoring, and close-out of clinical studies in accordance with ISO, GCP, FDA regulations, and Philips procedures.
- Protocol Compliance & Monitoring: Ensure strict adherence to study protocols and regulatory standards through site assessments, on-site and remote monitoring, training, and close-out visits. Proactively address deviations and ensure data accuracy and study integrity.
- Site & Investigator Support: Collaborate with study sites and investigators to provide guidance on protocol requirements, study procedures, and regulatory expectations.
- Regulatory Expertise: Serve as a subject matter expert on GCP, ISO, and FDA regulations related to human subject research in the medical device industry.
- Documentation Review: Review project documentation and deliverables for accuracy, completeness, and compliance with protocols and regulatory requirements.
- Process Optimization: Enhance study procedures to improve efficiency and data quality throughout the clinical research lifecycle. Perform data review and verification to ensure consistency.
- Issue Resolution: Ensure timely resolution of queries, issues, and discrepancies related to study conduct, data collection, and regulatory compliance.
- Cross-Functional Collaboration: Lead relationship management across Clinical and Medical functions, and collaborate with Regulatory, R&D, Quality, HEMAR, Biostatistics, Data Management, and Clinical Development teams.
- Study Design & Planning: Develop study plans and protocols that integrate regulatory requirements, GCP guidelines, and study objectives for robust execution.
- System Proficiency: Utilize clinical trial applications such as Electronic Data Capture (EDC), Electronic Trial Master File (eTMF), and Clinical Trial Management System (CTMS) with high competency.
- Communication & Leadership: Foster effective collaboration and communication across cross-functional teams and external partners to align on study goals and priorities.
- Performance Monitoring: Monitor study progress, analyze trends and deviations, and implement risk mitigation strategies to ensure timelines and budgets are met.
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.
Functie-eisen
To succeed in this role, you should have the following skills and experience:
- Bachelor's | Master's Degree in Life Science or equivalent. Experience in MedTech and understanding of Health Care Administration or equivalent.
- Minimum required Experience: 5-8 years of Clinical Study Management experience.
- Profound knowledge of clinical research process legislation and ICH-GCP guidelines.
- Strong knowledge of GCP, ISO 14155, and FDA regulations.
- Experience with clinical trial systems (EDC, CTMS, eTMF).
- Excellent organizational, analytical, and communication skills.
- Ability to work independently and lead cross-functional teams.
Interviews: 2 interviews, maybe 3 if needed to connect with the team.
Competenties
- Takes ownership of tasks and ensures high standards in study execution and compliance.
- Pays close attention to detail, especially in data handling and documentation.
- Works effectively with cross-functional teams and external partners to achieve shared goals.
Arbeidsvoorwaarden
- Please let us know salary indication for this position, we have a range.
- Duration: 1-year contractor role with potential for extension.
- Working model: Hybrid – 3 days onsite, 2 days remote.
- One-year contract with the intention to offer a permanent contract afterward.
- Discount on the collective health insurance plan via Zilveren Kruis.
- Access to the Yacht network of companies and industry specialists.
- Generous referral program – up to €1,500.
- Attractive pension scheme (STIPP).
- 8.33% holiday allowance.
- 13th Month
- Commuting reimbursement – €0.23 per kilometer up to 26km one way.
Bedrijfsinformatie
About Phillips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others. As a leading health technology company, it is our purpose to improve people’s health and well-being through meaningful innovation. We aim to improve 2.5 billion lives per year by 2030.
Over 125 years ago, Frederik and Gerard Philips started a small light bulb company in Eindhoven. Little did they realize that it would become a global force of innovation, committed to improving billions of lives worldwide. But it did.
Today, Philips is a world leading health technology company with a vision to make life better for people worldwide through meaningful innovation. Making good on this promise depends on our passionate, inspirational, collaborative and diverse team.
We have over 80,000+ brilliant people around the world but are always looking for more. Like-minded, motivated, focused minds to join us in creating a healthier, more connected society while tranforming themselves personally and professionally.
Working at Philips is more than a job. It's an experience filled with unexpected moments that will transform you in lasting and positive ways. Help us improve the world for the better while building a career that no one could have planned for. Even you.
Contactinformatie
Voor meer informatie neem contact op met Nicole Miggels 06-13897074
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contact
Nicole Miggels
nicole.miggels@yacht.nl
06-13897074
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