Overview:
Responsibilities:

• Acts as an SME on e TMF application features related to TMF Operations, TMF
  processes, document identification/filing.
• Adheres to the TMF Plan/Index created by Lead/Senior TMF Specialist and ensures that TMF document collection is in line with the TMF Plan/Index.
• Contributes to the identification of expected documents based on filed documents.
• Ensures the TMF file structure follows applicable company approved TMF
  configuration, regarding ICH Guidelines for Good Clinical Practice, Good
  Documentation Practices and the TMF Reference Model, as required.
• Contributes to SOPs (Project and Corporate), company guidelines, work instructions and templates (e.g., Quality management, reports and metrics, TMF quality control (QC)/ quality assurance (QA) activities, etc.) to ensure that TMF Operations tasks are performed in adherence with ICH/GCP/regulatory guidelines and best practices.
• Support implementation of features of Veeva Vault e TMF system in conjunction with the Clinical Systems Manager.
• Acquires expertise in e TMF applications used for studies where sponsor e TMF is chosen as TMF repository.
• Contributes to streamlining the processes and implementing automation such as VBA macros, Robotic Process Automation (RPA), system integration, Artificial Intelligence (AI)/Machine Learning (ML).
• Perform tasks within e TMF application to maintain the lifecycle of the TMF (e.g., EDL maintenance, reports and metrics, etc.)

Qualifications:

• Bachelor's degree requited, preferably in scientific discipline.
• Incumbent typically will possess 0 to 3 years of Clinical Operations/Filing documents
  experience in TMF Operations.
• Knowledge of GCP and TMF governing regulations, such as the TMF
  Reference Model required.
• Knowledge of filing procedures and e TMF application is mandatory.
• Experience in Veeva is desirable.
• Excellent verbal and written presentation, and communication skills along with fluency in English are necessary.