Document Management Associate

该职位来源于猎聘 Brief Position Description: The Document Management Associate (DMA) 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 Minimum Qualifications &

Experience: At least Bachelor's degree in life sciences, Pharmacy or Biotechnology 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.

Responsibilities Will receive all study documentation for assigned projects; DMA will set up, receive, track and maintain electronic or paper TMFs according to the requirements of ICH GCP and Novotech (or client) SOPs DMA will review each document as received for quality to ensure the document meets regulatory requirements, ALCOA principles, Novotech essential document requirements and - Good - Documentation Practices. DMA will work with the project team to ensure TMF is always inspection ready. Confirm that documents are filed under the correct TMF artifact in accordance with TMF reference model or sponsor specific TMF Index where applicable.

Identify duplicate, incorrect, incomplete or poor-quality documents and initiate appropriate corrective actions. Ensure document naming conventions comply with organizational or sponsor standards. Communicate review findings to document owners or relevant stakeholders in accordance with organizational standards.

Track and follow up on outstanding QC observations until closure. 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.

Support root cause analysis and implementation of corrective and preventive actions where applicable Resolves any internal quality control findings and audit findings. 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. Demonstrate a thorough understanding of and adhere to organizational policies, SOPs, and processes relevant to DMA role.

Maintain a strong quality mindset in all activities and uphold the organization's values and professional standards while representing the company in all interactions. Participate in team meetings, knowledge-sharing sessions and training activities, and contributing to the development of clinical processes, quality enhancement activities 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. 该岗位全国城市可看