The role involves supporting Global Study Leaders by initiating and maintaining electronic Trial Master Files (eTMF) in compliance with ICH/GCP guidelines
Job Summary
The role involves supporting Global Study Leaders by initiating and maintaining electronic Trial Master Files (eTMF) in compliance with ICH/GCP guidelines.
Candidates will collaborate with internal teams and external vendors to manage regulatory documents, study budgets, and clinical trial transparency activities.
The position requires excellent attention to detail and the ability to coordinate administrative tasks, meetings, and logistics throughout the study lifecycle.
Matching Summary
The role involves supporting Global Study Leaders by initiating and maintaining electronic Trial Master Files (eTMF) in compliance with ICH/GCP guidelines.
Skills & Requirements
Must-have
ICH/GCP compliance knowledge
eTMF setup and maintenance
Strong organizational skills
English verbal and written communication
Experience with clinical trial tools
Nice-to-have
Ability to train others on procedures
Project improvement experience
Presentation material creation skills
Independent work capability
High volume multitasking ability
Key Requirements
Education in medical or biological sciences preferred