Description
Summary:This position reports to the Clinical Operations department and has overall responsibility for developing, implementing, managing and maintaining Clinical Trial Master File (CTMF) systems according to FDA GCP requirements, ICH GCP requirements and typical pharmaceutical and biotech industry practices.
Duties:
- Develops document management systems to meet the needs of the Clinical Development department, including paper-based CTMF storage and maintenance systems, as well as electronic CTMF systems (eCTMF).
- Develops, implements and maintains CTMFs for all clinical trials.
- Interacts with Clinical Development department staff and relevant cross-functional departments to establish priorities and deadlines for processing and filing of CTMF required documents.
- Ensures all required CTMF documents are filed, tracked, maintained, and archived in accordance with regulatory requirements and procedures and processes.
- Manages and controls the paper-based CTMF storage room and its contents.
- Manages and controls the eCTMF storage and maintenance systems.
- Creates systems to ensure that CTMF documents are filed correctly, easily retrievable, and maintained in accordance with all applicable regulatory requirements and procedures and processes.
- Develops and manages the archiving systems and retrieval of archived CTMF documents.
- Functions as the Subject Matter Expert for CTMF document management systems and processes.
- Provides CTMF support and guidance for internal and external CTMF audits.
- Provides CTMF support and guidance for US and Ex-US regulatory authority inspections.
Skills/Education
- Established experience and knowledge of general CTMF systems and standards.
- Established experience and knowledge of paper-based document CTMF systems.
- Established experience and knowledge of electronic CTMF systems.
- Established experience providing CTMF support for US and Ex-US regulatory authority inspections
- Demonstrated knowledge of US and Ex-US regulatory authority CTMF requirements.
- Proficient in creation of document tracking systems and use of Adobe Acrobat and MS Office Suite.
- Must have Bachelor's Degree or equivalent with a minimum of 8 years of relevant pharmaceutical or biotech CTMF development and management experience, or equivalent experience.
To find out more about Real please visit www.realstaffing.com