Responsibilities
? 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.
? 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.
? DMA will review each document as received for quality to ensure the document meets Novotech essential document requirements; will work with the project team to ensure study documents are of high quality.
? 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.
? 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.
? Adheres to TMF SOPs, KPIs and relevant TMF process-supporting guidance.
? Performs interim eTMF exports/uploads for the sponsor or 3rd party, if applicable to the assigned project.
? Runs monthly reports to ensure accuracy of the files by performing file reviews.
? Prepares the TMF for delivery at study closeout.
? Reviews and prepares the TMF for audits and TMF reviews; Provide support to TMF Operations during audits and/or regulatory inspections.
? Resolves any internal quality control findings and audit findings.