- Collaborate with the clinical and regulatory affairs team to prepare study documents, including protocols, Investigator Brochures, Case Report Forms (CRFs), and related materials, supporting the initiation of new studies and amendments integrating ONWARD Technology
- Work closely with clinical sites to ensure compliance with applicable regulations and standards (e.g., ISO 14155), promoting good clinical practice and effective data collection strategies.
- Collect and process field data, including adverse events, device deficiencies, and other study-related information, in accordance with ONWARD’s Quality Management System.
- Analyze and summarize data collected from clinical studies to support study reporting and provide rationale to guide ONWARD’s pipeline development.
- Conduct literature reviews and searches as needed to support clinical and regulatory activities.
- Assist the team with regulatory submissions, documentation, and compliance activities as required.
ultime offerte
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