Job opening - Clinical Study Manager in Drachten

summary

drachten, friesland
€6,500 per month
permanent

job category
human resources

job details

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 ...

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

experience
8
skills
- 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.
qualifications
HBO

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