The Senior Document Management Associate (SDMA) will provide support for Trial
Master File (TMF) activities to the clinical teams for all assigned projects.
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.
Responsibilities
1. Senior DMA will have a dual responsibility of working on document upload and
document QC processes.
2. Senior DMA will also play an key role in mentoring and training the new
DMA team.
SDMA as a document uploader
1. Will receive all study documentation for assigned projects; DMA will set up,
receive, track and maintain electronic or paper TMFs according the requirements
of ICH GCP and Novotech (or client) SOPs.
2. DMA will use all required study systems to ensure all study documents are
filed appropriately throughout the entire study; including SharePoint and paper
and electronic TMFs; all documents are to be scanned, uploaded, tracked and
filed according to Novotech (or Clients) SOPs.
3. DMA will review each document as received for completeness and quality to
ensure the document meets Novotech essential document requirements; will work
with the project team to ensure study documents are of high quality.
4. DMA will provide reports on study document quality and collection practices
of the team and provide updates to the study team to ensure all documents are
collected in a timely manner.
5. Performs interim eTMF exports/uploads for the sponsor or 3rd party, if
applicable to the assigned project.
6. Ensure the TMF is ‘inspection ready’ at all times and trial master file
documents are filed contemporaneously in a timely manner, in accordance with
project timelines.
7. Adheres to TMF SOPs, KPIs and relevant TMF process-supporting guidance.
8. Prepare