You will be responsible for:
- Participates in the design, planning, implementation and overall direction of clinical research projects; may contributes technical and clinical operation expertise (if apply).
- Plan and prepares studies, under supervision (if apply), including but not limited to site qualification, regulatory submission (e.g. HGRAC, EC and/or NMPA), study supply, site initiation, routine monitoring and close-out activities.
- If, apply reviews study protocols, reports and manuscripts. Contribute technical and clinical operations expertise for these documents.
- If apply, works with Data Management and Biostatistics staffs on the design of documents and processes for the collection of study data from participating sites.
- Collects and maintains legal and regulatory documentation throughout a study.
- Assumes responsibility for training and coordinating certification of study site personnel.
- Ensures accurate and complete study management/data collection and transfer to data management
- Ensures study conduct and execution at site compliance with regulations and study protocol, and timely escalate identified risks/issues to investigator, project responsible and line manager for resolution. Implement CAPAs (as apply).
- Conducts reference material testing in-house.
- Organizes investigator meetings, as necessary.
- Conduct Other projects or tasks assigned by line manager
- Conduct business in full compliance including but not limited to Roche Secure, Roche Behavior in Business, Roche Competition Law Interactive Dialogues, Roche Safety, Security Health and Environmental Protection.
You should have:
- At least Bachelor degree in medical science, preferably in clinical medicine, medical laboratory, biochemistry, pharmacology, bio-engineering and biology.
- Proficiency in English language skills.
- Good command of MS office software application.
- Understand pharmaceutical and/or medical device regulation and ICH/GCP.
- At least 2 years of working experience in clinical research, clinical project management, data management in clinical medicine, CRO, pharmaceutical, Medical Device, or in-vitro Diagnostics industries.
- Effective oral and written communication skills; able to get ideas across face-to-face, in group settings as well as in presentation.
- Approximately 30% of time local and/or international travel.
- According to the "Quality Management Regulations for Medical Device Management" and the "Regulations on Quality Management of Pharmaceutical Products", health checks should be conducted at least once a year; if you have infectious diseases or other diseases that may contaminate medical devices or drugs shall not be engaged in related work.
罗氏是一家提供均等机会的雇主。Research & Development、 Research & Development > Clinical Development