The Clinical Document Management Associate (CDMA) will provide support for Trial Master File (TMF) activities to the clinical teams. This role will be responsible for working with study teams, both internal and external, to manage Trial Master Files (TMF), both electronic and paper in format according to project requirements, ICH GCP guidelines local/global regulatory requirements and Novotech/Client SOPs.
Will receive all study documentation for assigned projects; CDMA will set up, receive, t rack and maintain electronic or paper TMFs according the requirements of ICH GCP and Novotech (or client) SOPs. CDMA will use all required study systems to ensure all study documents are filed appropriately throughout the entire study; including SharePoint, paper and electronic TMFs; all documents are to be scanned, uploaded, tracked and filed according to Novotech (or Clients) SOPs. CDMA 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. CDMA 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. Runs and maintains department reports. Creates checklists and daily quality control schedules. Performs other special projects or tasks related to the TMF, which may include, but are not limited to, paper file location organization and archived study maintenance. Be aware of and adhere to company processes in areas relevant to a CDMA. Be quality-minded in performance of duties. Adhere to Novotech policies and be mindful of the role of Novotech ambassador when carrying out CDMA role. Participate in activities of the Clinical Operations department, including attendance at company/departmental meetings, and contributing to the development of clinical processes and SOPs. Understand the responsibilities of Novotech as a service provider in the pharmaceutical industry and ensure all communications with external parties present a positive professional image of the company .
At least 12 months experience in a clinical research organization or equivalent. Practical experience in handling Trial Master File activities including Paper or electronic-TMF (eTMF). Prior background in the pharmaceutical, CRO or healthcare industry is advantageous. ,