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eTMF Lead
BiomapasRO3 days ago
Job type
- Quick Apply
Job descriptionUniversity degree in Life Science field Solid background of work with Veeva Vault eTMF system 3-5 year’s experience in Clinical Research field Comprehensive knowledge of ICH GCP and other requirements for Essential records Experience in process development and implementation Risk Management skills Attention to detail and time-management skills Professional growth and career opportunities International team and environment Bonus based on annual performance Personal accident and business trip insurance Influenza vaccines Rewarding referral policy Workplace establishment allowance Flexible working hours Team building, global meetings, B active events
Join our Global Clinical Research team as an eTMF Lead.
eTMF lead is responsible for eTMF management, including adaptation of Veeva Vault system to the needs of the company and clients, risks management, processes development.
Position is remote / home-based in any European country.
Responsibilities :
- Develop eTMF structure and processes in close cooperation with internal team
- Support in filing documentation in eTMF and quality checks
- Track eTMF metrics compliance in frames of audit readiness concept
- Coordinate oversight of eTMF for assigned projects from the beginning till the end
- Create and maintain comprehensive project documentation
- Develop and update SOPs, WINs in accordance with GCP and local legislation
- Identify quality issues within the project to implement appropriate corrective and preventive action plans
- Lead problem solving and resolution efforts
- Plan and conduct system trainings for internal and external stakeholders
- Support business development by providing input and / or develop proposals for new projects
- Act as Point of Contact for both Internal and External stakeholders
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