Salary
💰 $239,600 - $299,600 per year
About the role
- Facilitate generation, author, update, and/or review key documents, including protocols, synopses, amendments, informed consent documents, Investigator Brochures, clinical study reports, and regulatory submissions
- Provide scientific and medical support during conduct of a clinical trial; respond to questions from sites, IRBs/IECs, Health Authorities, and CROs
- Build and maintain investigator networks; organize and present at key opinion leader advisory boards and investigator meetings
- Develop clinical program strategy and ensure activities are within scope, budget, and timelines
- Build relationships with internal experts; train BeOne colleagues, CRO staff, and study site staff
- Manage budgets, track goals, and ensure compliant business practices
- Contribute to therapeutic area/indication research and competitor analysis
Requirements
- Facilitate generation, author, update, and/or review key documents (protocol concepts, synopses, protocols, amendments, informed consent documents, Investigator Brochures, clinical study reports, etc.)
- Provide scientific and medical support throughout conduct of a clinical trial; respond to questions from sites, IRBs/IECs, Health Authorities, and CROs
- Build and maintain investigator networks; organize and present at key opinion leader advisory boards and investigator meetings
- Partner with clinical operations and other functions for successful implementation of clinical studies
- Lead training of BeOne colleagues, CRO staff, and study site staff on therapeutic area and protocol
- Develop, track, execute and report on goals; support budget planning and management
- Identify continuous process improvement opportunities
- Build external vendor relationships and contribute to vendor/ investigator selection
- Represent a clinical study or development program on teams or subteams