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IQ
IQVIA RDS GmbH
23d ago

GCP Archivist, Sponsor-Dedicated(m/w/x)

Basel
Full-timeOn-siteExperienced

Description

You will ensure the integrity of clinical trial records by managing complex archives and overseeing vendor performance to meet strict regulatory standards and business needs.

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Requirements

  • Bachelor’s degree, equivalent, or industry experience
  • Experience in clinical R&D or CROs
  • Experience in clinical documentation or records management
  • Strong influencing and presentation skills
  • Effective communication skills at all levels
  • High organisational awareness
  • Experience in multi-disciplinary and cross-cultural teams
  • Negotiation, problem solving, and conflict resolution
  • Trusted relationship building with stakeholders

Education

Bachelor's degree

Work Experience

3 - 4 years

Tasks

  • Manage archived records across multiple platforms
  • Collaborate with business and technical stakeholders
  • Maintain physical records in onsite and offsite archives
  • Deliver archiving services per regulatory standards and SLAs
  • Provide subject matter expertise for archiving systems and processes
  • Support audit and inspection readiness activities
  • Identify root causes and deliver corrective actions
  • Develop training materials for electronic and physical records
  • Execute vendor oversight and monitor service metrics
  • Act as a point of escalation for archiving issues
  • Implement improvements to archive operations and services
  • Lead innovation projects to enhance archiving capabilities

Languages

EnglishBusiness Fluent

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