TMF Lead II (LATAM)

Experience with eTMF systems and vendors

Working knowledge of FDA & ICH/GCP regulations and guidelines

Any data provided as a part of this application will be stored in accordance with our

Ensure that TMF document review and processing, periodic quality review, set up, maintenance, finalization and archival of study TMFs is completed in a timely manner and with a high level of quality

Ensure entire study team understands expectations, project-specific aspects of the TMF, and manage communication of any changes in the TMF Plan or Index to the project team

Ensure that TMF Risks are identified and appropriately documented and mitigated

Monitor and report on TMF Health and Metrics and escalate non-compliances and potential issues to internal team and Senior Leadership as required

Identify trends, risks, and overall status of the TMF and suggest mitigation strategies

Support Audits and Inspections and finding resolutions and participate in Audit/Inspection interviews with support and oversight from Line Management