Senior Document Management Associate
IndiaFull-time2–5 yrsPosted over a month ago
Mid-level mechanical and production role at Fa Euzi Saasfaprod1. Needs 2+ years.
About the role
This role will be responsible for working with study teams, both internal and external, to manage both paper and electronic Trial Master Files (TMF), according to project requirements, ICH GCP guidelines, local/global regulatory requirements and Novotech/Client SOPs. The SDMA will also be responsible for performing comprehensive QC reviews.
What you'll do
- Senior DMA will have a dual responsibility of working on document upload and document QC processes
- Senior DMA will also play an important role in mentoring and training the new DMA team
- SDMA as a document uploader
- Receive all study documentation for assigned projects; DMA will set up, receive
- DMA will use all required study systems to ensure all study documents are filed appropriately throughout the entire study
What you need
- Clinical research
- CRO
- Quality control
- SOP writing
- Maintenance