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.
• 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 DMA. Be quality minded in performance of duties. Adhere to Novotech policies and be mindful of the role of Novotech ambassador when carrying out DMA 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.
Minimum Qualifications & Experience:
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.