You should be responsible for:
- As a project leader to lead the whole study activities, including but not limited to site selection, Ethics committee review, study agreement signing, investigator meeting, enrollment, trial master file management, site monitoring, source data verification and site close-out.
- As a project leader to manage and track the study timeline, study budget and products of company sponsored studies.
- Ensure the clinical studies are in compliance with local regulations, ICH GCP and Roche SOPs.
- Manage the review and approval processes of investigator initiated studies and track the study progress.
- Work with global MSA and clinical operation team to have cooperation on global multicenter studies.
- Establish and maintain the good relationship with KOLs, investigators and sites.
- Assist line manager in other clinical study related tasks or other routine tasks.
- 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:
- Master / Bachelor Degree in Clinical Medicine or Clinical laboratory education background, PhD Degree is preferred.
- 3 +years of diverse healthcare experience in medical or clinical research in pharmaceutical, medical device or IVD companies.
- Marketing Expertise
- Planning & Organizing
- Internal Cooperation
- Medical-related Product & Applications Expertise
- KOL Orientation & Relationship Management
罗氏是一家提供均等机会的雇主。Research & Development、 Research & Development > Clinical Operations