The Senior Document Management Associate (SDMA) will provide support for Trial Master File (TMF) activities to the clinical teams for all assigned projects. This role will be responsible for working with study teams, both internal and external, to manage both paper and electronic Trial Master Files (TMF), according to project requirements, ICH GCP guidelines, local/global regulatory requirements and Novotech/Client SOPs. The SDMA will also be responsible for performing comprehensive QC reviews.
Responsibilities:
1. Senior DMA will have a dual responsibility of working on document upload and document QC processes.
2. Senior DMA will also play an important role in mentoring and training the new DMA team.
SDMA as a document uploader
1. 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.
2. 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.
3. DMA will review each document as received for completeness and quality to ensure the document meets Novotech essential document requirements; will work with the project team to ensure study documents are of high quality.
4. 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.
5. Performs interim eTMF exports/uploads for the sponsor or 3rd party, if applicable to the assigned project.
6. 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.
7. Adheres to TMF SOPs, KPIs and relevant TMF process-supporting guidance.
8. Prepares monthly reports to ensure accuracy of the files and provides to the project teams.
9. Prepares the TMF for delivery at study closeout.
10. Reviews and prepares the TMF for audits and TMF reviews; Provide support to
the project team during audits and/or regulatory inspections.
11. Resolves any internal quality control findings and audit findings.
12. Runs and maintains department reports.
13. Creates checklists and daily quality control schedules.
14. 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.
15. 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.
16. Participate in activities of the Clinical Operations department, including attendance at company/departmental meetings, and contributing to the development of clinical processes and SOPs.
17. 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.
SDMA as a QC reviewer.
1. Senior DMA will work closely with Central Filing Team Lead for assignment of projects for QC review.
2. Ensure all assigned project QC review are performed after every quarter or as per the study plan.
3. Senior DMA will be preparing a QC checklist and shared with project team to resolve and track any queries. 4. Senior DMA will ensure that all queries are responded within the stipulated
timeline.
Requirements :
• At least more than 2 years of experience in a clinical research organization or equivalent role.
• 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.