You are responsible for
• Leads the management of clinical studies, in compliance to all applicable regulations (like ISO, GCP and FDA) and Philips procedures.
• Ensures strict adherence to study protocols, regulatory standards, and Philips Processes/Procedures through meticulous execution of site assessment, on site and remote monitoring and training, and close-out visits, proactively addressing deviations and ensuring data accuracy and study integrity.
• Collaborates with study sites and investigators to provide support and guidance on protocol requirements, study procedures, and regulatory expectations.
• Acts as a subject matter expert to provide guidance on GCP, ISO and FDA regulatory requirements for the conduct of research involving human subjects is required in the medical device industry.
• Reviews project documentation and deliverables for accuracy, completeness, and compliance with established protocols and regulatory requirements, and GCP guidelines.
• Enhances study procedures and processes to optimize efficiency and data quality throughout the clinical research lifecycle and performs data review and verification activities to ensure accuracy and consistency of clinical trial data.
• Ensures resolution of queries, issues, and discrepancies related to study conduct, data collection, and regulatory compliance in a timely and effective manner.
• Leads relationship and management activities relationships within the Clinical and Medical functions, as well as cross-functionally with Regulatory, R&D, Quality, HEMAR, Biostatistics and Data Management, Clinical Development, and other internal partners to achieve project objectives.
• Develops study plans and protocols, integrating regulatory requirements, Good Clinical Practice (GCP) guidelines, and study objectives to ensure robust study design and execution.
• Utilizes clinical trial applications including Electronic Data Capture (EDC), Electronic Trial Master File (eTMF), and Clinical Trial Management System (CTMS) with high level of competency.
• Fosters effective collaboration and communication with across cross-functional teams and external collaborators, facilitating problem-solving, decision-making, and alignment on study objectives and priorities throughout the project lifecycle.
• Monitors study progress, conducting in-depth analysis of trends and deviations to inform proactive decision-making, risk mitigation strategies, and continuous improvement initiatives, ensuring budgets and schedules meet corporate requirements.
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:
Experience:
• Minimum 5 years of experience in Medical device, pharmaceutical industry, or other regulated environment experience is required, with medical device clinical study experience high preferred.
• Profound knowledge of clinical research process legislation and ICH-GCP guidelines.
Preferred Skills:
Technical / Functional Skills:
• Good Clinical Practices
• Clinical Research
• Clinical Study Management
• Electronic Data Capture (EDC)
• Clinical Trial Management Systems (CTMS)
• Regulatory Compliance
Nice to have
• Data Analysis & Interpretation
• Documentation & Reporting
• Budget Management
• Project Management
• Document Auditing
• Document Management
• Microsoft Office
• Site Management
Competenties
Minimum 3 days in Drachten
Uiteraard staat deze vacature open voor iedereen die zich hierin herkent.
contact
Nikhil Kumar
nikhil.kumar@yacht.nl
020 519 7007
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