oracle
Senior Document Management Associate
Acrostar Site Management Co., Ltd.
IND
Onsite
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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
Senior DMA will have a dual responsibility of working on document upload and document QC processes. 2.
Senior DMA will also play an important 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.
Prepares monthly reports to ensure accuracy of the files and provides to the project teams. 9.
Prepares the TMF for delivery at study closeout. 10.
Reviews and prepares the TMF for audits and TMF reviews; Provide support to the project team during audits and/or regulatory inspections. 11.
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