Description
Primary responsibilities include, but not limited to:- Develops and oversees CTMF document control policies, procedures, processes and systems in accordance with all applicable regulatory requirements (including paper-based CTMF storage and maintenance systems as well as electronic CTMF systems)
- Interacts with Clinical Development department staff and relevant cross-functional departments to establish priorities and deadlines for processing and filing of CTMF required documents
- Provides support and guidance for internal and external CTMF audits
- Provides support and guidance for US and Ex-US regulatory authority inspections
- Develop and/or update Standard Operating Procedures and Work Instructions
Skills Requirements and Education:
- 5+ years clinical operations experience within drug development
- Experience collecting and managing clinical trial documents from sites
- Knowledge of HIPAA regulations as well as GCP / ICH guidelines
- Bachelors Degree required
- Ability to independently and effectively manage assigned tasks and projects
- Proficient in creation of document tracking systems and use of Adobe Acrobat and MS Office Suite
- No travel is required
To find out more about Real please visit www.realstaffing.com