You will be responsible for:
- Provides leadership in complex clinical research activities including: reaching agreement on study goals with other functional areas, coordinating and overseeing study monitors and investigators to ensure compliance, monitoring, analyzing and interpreting study data, and preparing reports.
- May contribute to the design of clinical studies. Independently plans and implements complex or significant clinical research studies and projects.
- Ensures that goals and activities of own work or project team is aligned with the objectives of the area(s) and the organization.
- Assumes responsibility for coordinating the activities of relevant colleagues within the company and investigators to ensure compliance with the overall scientific objectives.
- Lead feasibility and regulatory submission (e.g. HGRAC, EC and/or NMPA submissions), execute monitoring plan, oversee, develop and implement CAPAs.
- Travels to field sites to monitor studies or coach and train co-workers at the CRA level and below to ensure they are in compliance with regulations, SOPs and study protocols.
- Work with project responsible, Medical Writer, Data Management and Bio statistical staffs on the design of study protocols, reports and other study documents like ICF. Contribute technical and clinical operations expertise for these documents and clinical operation SOPs.
- Works with Data Management and Bio statistical staffs on the design of documents and processes for the collection of study data from participating sites.
- Develop and maintain study supplies/instruments plan of assigned studies, monitor the supplies/instruments ordering, distributing, storage, reconciling and recycling or destroying.
- Ensures accurate and complete study management/data collection and transfer to data management. Collects and maintains legal and regulatory documentation, as applicable.
- Coordinates or conducts reference material testing in-house.
- Organizes investigator meetings, as necessary.
- May represent the company as primary contact on projects and conduct other projects or tasks assigned by line manager.
- If apply, develop and maintain a good working relationship with BAs and other dept. to support the cross-functional projects
- 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 5 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
罗氏是一家提供均等机会的雇主。Research & Development、 Research & Development > Clinical Operations