eTMF Specialist

Position summary

Key stakeholder concerning further optimization of eTMF structure and processes in close cooperation with cross-functional teams, IT department and external vendors to improve user-friendliness.

Performs detailed eTMF quality checks/reviews with follow-up for missing documentation in collaboration with Clinical Project Manager and Clinical Project Assistance across the Sotio clinical development programs.

Ensures eTMF inspection readiness at any time.

Key Activities and Responsibilities

  • Responsible for initial set-up and maintenance of the eTMF structure
  • Responsible to monitor vendor (CRO) eTMF performance to ensure sponsor oversight
  • Participates in eTMF Veeva Vault regular updates evaluation and implementation together with IT department
  • Plans and conducts system trainings for internal and external users and provides process guidance as required

Competences, Skills and Qualification

  • Bachelor degree in a science-related field
  • 2 years of eTMF management experience at a biotechnology, pharmaceutical company or Clinical Research Organization
  • Solid experience with eTMF system software - Veeva Vault knowledge is preferred
  • Sound knowledge of ICH-GCP guidelines and regulatory requirements related to clinical document management
  • Strong clinical, technical and ideally oncology disease area expertise
  • Excellent communication, interpersonal and organizational skills
  • Fluent English communication and writing skills
  • Attention to detail and timelines


Jankovcova 1518/2, 170 00 Praha 7, Česká republika

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