Document Management Associatee (Novotech)

Roles and Responsibilities

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.