eTMF Specialist

Position summary

Works on further development of eTMF structure and processes in close cooperation with functions within Clinical Development, IT department and external vendors.
Performs detailed eTMF quality checks/reviews with follow-up for missing documentation in collaboration with Clinical Project Manager and Clinical project Assistance.
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
  • 2 years experience with Veeva Vault eTMF system software or similar eTMF System
  • Sound knowledge of ICH-GCP guidelines and regulatory requirements related to clinical document management
  • Strong clinical, technical and oncology disease area expertise
  • Excellent communication, interpersonal and organizational skills
  • Fluent English communication and writing skills
  • Attention to detail and timelines

Location

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

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