Philips
Clinical Development Scientist (Contract)
Location: Eindhoven, High Tech Campus
Duration Assignment: 12 months (with possible extension)
Contract: via a Randstad company
Hours/week: 40
Budget range: €3,850 - €5,500
In this role, you will have the opportunity to: Make life better!
In this role, you challenge the complexities of clinical development, focusing on risk management and benefit-risk analysis to ensure the safety and effectiveness of innovative medical products.
When you choose to work at Philips, you’ll work on life-changing projects; and contribute to innovative health technologies and solutions that improve billions of lives around the world.
You will be responsible for:
Conducting benefit-risk analysis and contributing to risk management throughout product lifecycles.
Collecting, appraising, and analyzing clinical data related to medical products.
Writing clinical documentation, including Clinical Evaluation Reports (CERs) and Post-Market Clinical Follow-up Reports (PMCF).
Collaborating with internal (project owners, regulatory, statisticians, post-market surveillance, risk management, etc.) and external (clinical consultants, regulatory agencies, etc.) stakeholders to ensure comprehensive clinical evidence analysis.
Ensuring appropriate dissemination of clinical evidence through Clinical Study Reports (CSRs), CERs, and PMCF Reports.
Supporting clinical trials and product approvals in the USA, EU, and ROW.
Leading clinical risk assessments from ideation to market introduction.
Reviewing and optimizing workflows, SOPs, and document preparation procedures for the Clinical Development department.
To succeed in this role, you should have the following skills and experience:
Preferably an M.D., Master’s, or Ph.D. in Biomedical Science or a health-related field with 3–5 years of experience in the medical device or pharma industry.
Expertise in benefit-risk analysis and clinical risk management.
Experience in vigilance reporting and/or harm reviews for medical products.
Training and experience in medical writing, systematic reviews, and clinical data appraisal; experience with MDR-compliant CERs and PMCFs is a plus.
A demonstrated working knowledge of GCP, ICH guidelines, ISO14155, FDA regulations, and EU regulations.
Experience with clinical investigations design, biostatistics, and research methodology.
Proven ability to deliver clinical results on time, within budget, and in compliance with SOPs and regulations.
Strong collaboration skills across multidisciplinary teams and with external stakeholders.
Professional proficiency in reading, writing, and speaking English.
In return, we offer you:
For this project, you’ll work for Philips and become a contract or permanent employee of a Randstad company. As a contractor at Philips, you'll enjoy cutting-edge challenges and unexpected experiences that make you a more in-demand professional.
Why work on a project at Philips?
If you’re looking for meaningful work and a chance to tackle complex challenges, broaden your skills and expertise, and become an even more sought-after professional, you’ll find all that and more with project work at Philips.
The Randstad companies are responsible for finding talent to provide services at Philips. If you are selected to provide services for Philips, you will be employed by Randstad and will not be an employee of Philips.