Trial Master File Specialist (TMFS) II - TMF and ALCOA principles experience required
Ergomed
Ključne odgovornosti
- Establish and maintain Trial Master Files per project guidelines and SOPs
- Process, index, and quality-check documents using ALCOA+ principles
- Serve as primary contact for all TMF-related project activities
- Support audit preparation, attend audits, and oversee corrective action plans
- Coordinate TMF reconciliation, archiving, and client file delivery upon study closure
Zahtevi
Potrebne kvalifikacije
Iskustvo
TMF maintenance and quality verification experience
Administrative background in international clinical research
Meke veštine
Independent responsibility management and follow-up capability
Fluent English communication skills, written and verbal
Poželjne kvalifikacije
Alati i tehnologije
Advanced Excel proficiency
Originalni opis
Ergomed seeks a Trial Master File Specialist II to establish, maintain, and oversee TMF documentation for clinical research projects. The role involves document processing, quality assurance, audit support, and regulatory compliance oversight, requiring ALCOA principles expertise and clinical research experience.
Responsibilities
- Establish and maintain Trial Master Files per project guidelines and SOPs
- Process, index, and quality-check documents using ALCOA+ principles
- Serve as primary contact for all TMF-related project activities
- Support audit preparation, attend audits, and oversee corrective action plans
- Coordinate TMF reconciliation, archiving, and client file delivery upon study closure
Requirements
- TMF maintenance and quality verification experience
- Knowledge of ALCOA+ principles and regulatory standards
- Administrative background in international clinical research
- Advanced Excel proficiency
- Independent responsibility management and follow-up capability
- Fluent English communication skills, written and verbal
Oglas je objavljen pre 3 dana
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