Senior Clinical Data Manager

hace 1 semana


Ciudad de México, Ciudad de México IQVIA Argentina A tiempo completo

About the Role

We are seeking a skilled Sr TMF Analyst to join our team at IQVIA Argentina, working in a full home-based setting with a location in Mexico. This role offers an exciting opportunity to work on Trial Master File (TMF) management and provide operational support to clinical trial teams.

Key Responsibilities

  • Manage the sponsor TMF structure and records in the system, ensuring accuracy and completeness.
  • Create file plans for document requirements using Veeva Vault, our preferred eTMF platform.
  • Maintain expected numbers of documents in the sponsor eTMF by supporting signpost management.
  • Perform quality and completeness reviews of the TMF.
  • Support inspection readiness activities as needed.
  • Collaborate with other teams/roles to create training materials and job aids.
  • Resolve issues in collaboration with other teams, identifying gaps and escalating if necessary.

Requirements

  • Bachelor's degree, preferably in a scientific discipline, is required.
  • Demonstrated proficiency with TMF Management, with a minimum of 4 to 5 years of experience with eTMF systems/platforms.
  • Strong knowledge of DIA Reference Model for TMFs, ICH GCP, regulatory requirements, and regulations.
  • Familiarity with eTMF platforms, particularly Veeva Vault, is a plus.
  • Working knowledge of clinical research documents and study life cycle milestones in Veeva Set up, EDL management, tailoring.
  • Demonstrated current knowledge of ICH, GCP, and other regulatory guidance applicable to clinical documentation management.
  • Ability to work in a fast-paced environment with changing priorities.
  • Excellent communication and teamwork skills.
  • Attention to detail and accuracy in work.
  • Experience with Microsoft Office suite, with proficiency in Excel being a plus.

Estimated Salary Range: $65,000 - $85,000 per annum, based on qualifications and experience.



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