Buscojobs México | Sr Tmf Analyst

hace 2 días


veracruz, México Buscojobs México A tiempo completo

Job Overview
The Trial Master File (TMF) Analyst is responsible for management of sponsor TMF structure and records in the system and provides day-to-day operational support to the sponsor clinical trial teams on TMF structure management, TMF Quality review, and inspection readiness.

Essential Functions , includes but not limited to:

  • Responsible for management of expected TMF structure and records in the sponsor TMF Platform.
  • Able to create sponsor TMF platform (Veeva Vault) file plan for document requirement.
  • Maintenance of expected number of documents in sponsor eTMF by performing activities such as support in management of signposts.
  • Perform TMF quality and completeness review.
  • Support inspection readiness activities as needed.
  • Collaborate with the other teams/roles in the sponsor organization for creating training materials and job aids.
  • Support issue resolution in collaboration with other teams, identify gaps, and escalate if required to follow up and close the identified gaps and issues.

Qualification
• Bachelor’s degree, preferably in a scientific discipline, is required.
• Demonstrated proficiency with TMF Management. A minimum of 4 to 5 years of experience with eTMF system/platform.
• Must have strong knowledge of DIA Reference Model for TMFs, ICH GCP knowledge, regulatory requirements, and regulations.
• Strong knowledge of eTMF platforms (Veeva Vault is preferred).
• Understands the reports and complexity of study life cycle milestones in Veeva Set up, EDL management, tailoring.
• Working knowledge of clinical research documents.
• Demonstrated current knowledge of ICH, GCP, and other regulatory guidance as applicable to management of clinical documentation.
• Ability to work in an extremely fast-paced environment with changing priorities.
• Ability to work collaboratively and cross-functionally.
• Attention to detail and accuracy in work.
• Skilled in verbal and written communication skills.
• Experience in Microsoft Office suite. Competency in Microsoft Excel is an added advantage.

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