- Identify candidate investigators considering qualification, experience, etc.
- Engage in feasibility and site selection process
- Support the selection of vendors including Clinical Research Organizations (CROs), if required
- Oversee overall clinical trial status including contracts/budget negotiation, regulatory/Ethics Committee (EC) submissions, start-up activities, issue management, and relationship management according to assigned role and responsibilities in each project
- Prepare clinical trial documents or provide relevant information to Regulatory Authority (RA) team for submission to regulatory authority for Investigational New Drug (IND) related work
- Review and manage the label of investigational product in collaboration with Regulatory Authority (RA) team
- Participate in the investigator’s meeting and initiation meeting to ensure CROs provide appropriate training to the relevant study staff and ensure proper study process and procedures are followed
- Oversee issue management, relationship management, monitoring and site closure, and data management according to assigned role and responsibilities in each project Perform regular quality oversight visits through Electronic Trial Master File (eTMF) functional Quality Check (QC), reviewing monitoring visit reports (MVRs), CRO oversight visit, etc.
- Proactively monitor study conduct and progress (e.g., study milestones, patient recruitment, protocol compliance, GCP/regulatory compliance etc.)
- Oversee the clinical operation performance by the CRO and proactively communicate with the Study Team to improve the quality
- Manage issues proactively through trouble shooting in collaboration with relevant stakeholders
- Manage Key External Experts (KEEs) with clinical science knowledge
- Coordinate/support activities associated with audits and regulatory inspections
- Prepare for and support publication (and publication material)
Administrative
Plans and manages the budget for the assigned projects
- Cooperates to generate any documents with diligent efforts
- Generates and revises internal client local SOPs in aligned with current activities
- Provides information and updates to the clinical development team leader and other related departments regarding
