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Document Management Associate

2+ years
Not Disclosed
10 Dec. 18, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Document Management Associate
Location: India

Job Description:

The Document Management Associate (DMA) will provide essential support for Trial Master File (TMF) activities to the clinical teams. This role involves managing both electronic and paper Trial Master Files according to project requirements, ICH GCP guidelines, regulatory requirements, and Novotech/Client SOPs. The DMA will work closely with study teams to ensure that all study documents are properly filed, maintained, and compliant throughout the entire study.

Responsibilities:

  • Document Management: Receive, track, set up, and maintain electronic or paper TMFs for assigned projects in compliance with ICH GCP and Novotech (or client) SOPs.
  • Study Systems Usage: Ensure all documents are filed appropriately using systems like SharePoint and other required study systems, ensuring timely uploading and scanning.
  • Quality Control: Review each document to ensure it meets Novotech's essential document requirements and work with project teams to maintain document quality.
  • Reports & Updates: Provide regular reports on document collection and quality to the study team to ensure all required documents are collected within project timelines.
  • Inspection Ready: Maintain the TMF in an ‘inspection ready’ state, ensuring all documents are filed promptly and accurately.
  • TMF Export/Upload: Perform interim eTMF exports/uploads as required for the sponsor or third party, if applicable to the assigned project.
  • File Review: Run monthly reports to review and ensure the accuracy of the files.
  • Study Closeout: Prepare the TMF for study closeout and ensure readiness for audits and regulatory inspections.
  • Special Projects: Participate in various tasks related to the TMF, such as paper file organization, archived study maintenance, and special projects as assigned.
  • Compliance & Process Adherence: Follow TMF SOPs and contribute to the development of clinical processes and SOPs. Adhere to company policies and ensure professional communication with external parties.

Minimum Qualifications & Experience:

  • Experience: At least 12 months of experience in a clinical research organization or equivalent, with practical experience in handling Trial Master File activities (paper or eTMF).
  • Industry Background: Prior experience in the pharmaceutical, CRO, or healthcare industry is advantageous.

Why Novotech?

Novotech offers a dynamic and inclusive work environment with flexible working options, paid parental leave for both parents, wellness programs, and continuous development opportunities. We are an equal opportunity employer committed to diversity, including LGBTIQ+, individuals with disabilities, and caregivers.