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gcp medical devices respiratory iso 14155 rbm๐ Description
- Manages study delivery per protocol and GCP/ISO 14155 requirements.
- Oversees study execution and regulatory compliance.
- Balances resources (time, money, people, equipment) with deliverables.
- Develops the clinical study budget; assists in quarterly reviews.
- Leverages cross-functional collaboration to improve processes.
- Oversees risk-based monitoring and addresses protocol deviations.
๐ฏ Requirements
- Bachelor's or advanced degree in a relevant scientific discipline.
- 3-5 years of medical device clinical project management experience.
- Experience with sleep and respiratory studies is required.
- In-depth knowledge of ICH-GCP, EMEA guidelines and related regulations.
- Proven ability to manage studies within timelines and budgets.
- Strong communication, negotiation, and mentoring skills.
๐ Benefits
- Global CRO with focus on quality and development.
- Training and career development opportunities.
- Equal opportunity employer with diverse workforce.
- Client-facing role with cross-functional collaboration.
- Global teams across 20+ countries.
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