Document Management Associate

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Role Summary

The Document Management Associate (DMA) will provide support for Trial Master File (TMF) activities to the clinical teams. This role is responsible for working with study teams (internal and external) to manage Trial Master Files (both electronic and paper formats) according to project requirements, ICH GCP guidelines, local/global regulatory requirements, and Novotech/Client SOPs.

Minimum Qualifications & Experience

• At least 12 months of experience in a clinical research organization or equivalent.
• Practical experience in handling Trial Master File (TMF) activities including Paper or eTMF.
• Prior background in the pharmaceutical, CRO, or healthcare industry is advantageous.

Key Responsibilities

• Receive, set up, track, and maintain electronic or paper TMFs according to ICH GCP and Novotech/Client SOPs for assigned projects.
• Use required study systems (including SharePoint and paper/electronic TMFs) to ensure documents are filed appropriately throughout the study (scanned, uploaded, tracked, and filed).
• Review each document upon receipt to ensure it meets Novotech’s essential document quality requirements.
• Provide reports on document quality and collection practices to the study team to ensure timely collection.
• Ensure the TMF is inspection-ready at all times and documents are filed contemporaneously.
• Adhere to TMF SOPs, KPIs, and relevant TMF process-supporting guidance.
• Perform interim eTMF exports/uploads for the sponsor or 3rd party, if applicable.
• Run monthly reports to perform file reviews and ensure accuracy.
• Prepare the TMF for delivery at study closeout.
• Review and prepare the TMF for audits/reviews; provide support to TMF Operations during audits and/or regulatory inspections.
• Resolve any internal quality control findings and audit findings.
• Run and maintain department reports; create checklists and daily quality control schedules.
• Perform special projects or tasks related to the TMF (e.g., paper file location organization, archived study maintenance).
• Participate in Clinical Operations department activities, including meetings and contributing to clinical processes and SOPs development.
• Ensure all communications with external parties present a positive, professional image of Novotech as a service provider.

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