Gcp Archivist, Sponsor-dedicated
vor 2 Wochen
**Job Overview**:
The GCP Archivist will be responsible responsible for delivery of archiving services for electronic and paper clinical trial related records in compliance with
appropriate regulations and to meet the business needs of the Sponsor.
**_ Location: office based in Basel, Switzerland _**
**Essential Functions**
- Act as Archivist, responsible for the management of archived records across multiple platforms. Collaborate closely with business and technical stakeholders to ensure records are maintained in compliance with regulatory standards and internal policies.
- Act as Archivist for physical records collections managed in local onsite CDGM archives and offsite storage.
- Ensure the archiving service for paper and electronic records is delivered in compliance with appropriate regulations and Sponsor's policies, and per agreed SLAs to meet business needs.
- 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.
**Ideal Background**:
- Bachelor’s degree or equivalent and relevant industry experience.
- Minimum of 3/4 years working in clinical research and development in the pharmaceutical industry (and/or Contract Research Organisations) with specific experience in clinical documentation and/or records & information management.
- Strong influencing and presentation skills. Ability to communicate
effectively at all levels.
- High organisational awareness, including experience working in multi
- disciplinary teams, across cultures and geographies.
- Good negotiation, problem solving and conflict resolution skills;
experience establishing trusted relationships with internal and external
stakeholders.
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