GCP Archivist / GCP Archivistess

Job Overview

The GCP Archivist will be responsible for the 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

• Serve as the Archivist, overseeing 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.
• Manage physical records collections located 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 the Sponsor's policies, according to agreed Service Level Agreements (SLAs) to meet business needs.
• Act as an Archiving Subject Matter Expert, supporting CDGM and business-driven projects and activities related to archive systems, processes, and archived records.
• Provide audit and inspection readiness support concerning archiving, contribute to root cause analysis, and assist in the identification and creation/delivery of Corrective and Preventive Actions (CAPAs).
• Serve as a Subject Matter Expert on archiving training materials, including formal and informal processes and tracking tools for electronic and physical clinical records.
• Execute vendor oversight plans related to archive staff and other third parties, monitor service metrics, and identify opportunities for improvement to the operating model. Act as a point of escalation for issues.
• Identify and implement improvements to archive operations and services.
• May act as the business lead for innovation projects aimed at enhancing archive services.

Ideal Background

• Bachelor’s degree or equivalent and relevant industry experience.
• Minimum of 3 to 4 years of experience in clinical research and development within the pharmaceutical industry (or Contract Research Organizations) with specific expertise in clinical documentation and/or records & information management.
• Strong influencing and presentation skills with the ability to communicate effectively at all levels.
• High organizational awareness, including experience working in multi-disciplinary teams across different cultures and geographies.
• Good negotiation, problem-solving, and conflict resolution skills, along with experience in establishing trusted relationships with internal and external stakeholders.

Apply online using the form below.

Only applications matching the job profile will be considered.