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![Cloudious LLC](https://media.trabajo.org/img/noimg.jpg)
Trial Master File Document Archivist Document Governance
1 month ago
Cloudious LLC is one of the fastest emerging IT Solutions and Services company headquartered in San Jose, CA with their global offices in Canada, EMEA & APAC.
We are currently hiring a seasoned Trial Master File Document Archivist Document Governance & Management who comes with a strong consulting mindset
Trial Master File Document Archivist Document Governance & Management
East Hanover, NJ (Onsite)
Long Term Contract
Must have: (Life Science Domain)
5 years working in clinical R&D pharmaceutical industry (and/or Contract Research Organizations) with specific experience in clinical documentation and/or records & information management
Proficiency and Expertise in the following areas:
Act as Archivist for sponsor Clinical Vault, actively engaging in the management of archived records in those systems, interacting with business and technical stakeholders
Act as Archivist for physical records collections managed in local onsite Document Governance & Management archives and offsite storage
Ensure the archiving service for paper and electronic records is delivered in compliance with appropriate regulations and sponsor policies, and per agreed SLAs to meet business needs
Act as Archiving subject matter experts supporting Document Governance & Management , business driven projects and activities relating to archive systems, processes and archived records
Provides audit/inspection readiness support in relation to archiving, contributes to root cause analysis identification and creation/delivery of CAPAs
Serves as Subject Matter Expert on archiving training materials, formal and informal processes and tracking tools for electronic and physical clinical records
Executes vendor oversight plans, in relation to archive staff and other third parties, monitors service metrics and identifies opportunities for improvement to the operating model. Acts as point of escalation for issues
Identify and implement improvements to archive operations and services. May act as business lead for innovation projects to enhance archive services