- To provide administrative support to the Clinical Quality Lead in various areas of inspection readiness, compliance and quality assurance
- Organizational Relationship
- Reports to the head of Strategic and Technical Operations and is overseen by the Clinical Quality Lead
- Managing outlook calendars
- Coordinates meetings
- Prepares and edits reports and presentations using MS Office software
- Organizes and maintains both electronic and paper files
- Coordinates and manages travel arrangements and prepares expense reports
- Replies to routine inquiries
- Provides project management assistance when necessary
- Expedites flow of work, and initiates follow-up when necessary
- Record minutes at meetings
- Works in concert with other administrative assistants
- Provides support in various areas of quality / compliance / inspection readiness including but not limited to: quality assessments, quality control tracking and metrics for various clinical trial processes
- Assists in data collection activities and maintains various spreadsheets; perform analysis of various data
- Provides project management support
- Documents and monitors project tasks and schedules and maintains list of actions/due dates/completion
- Participates in continuous improvement activities as required
- MS Excel Required 1-3 Years Intermediate
- MS Outlook Required 1-3 Years Intermediate
- MS PowerPoint Required 1-3 Years Intermediate
- MS Word Required 1-3 Years Intermediate
- 21 CFR Part 11 Desired 1-3 Years
- Project Timelines Project Management Required 1-3 Years
- Expert knowledge and proficiency with general administrative functions; proficiency in MS Word, Excel, PowerPoint, and Outlook; Internet; SharePoint, and ability to pick up other applications as needed
- Project management skills
- Quality and regulatory knowledge preferred, but not required
- Teamwork
- Highly flexible, a motivated individual who takes initiative
- Good communication skills (oral and written)
- Respect confidentiality
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