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