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, ensuring compliance with appropriate regulations while meeting the business needs of the Sponsor.

Location

Office based in Basel, Switzerland

Essential Functions

• Serve as the Archivist responsible for managing archived records across multiple platforms, collaborating closely with both business and technical stakeholders to ensure compliance with regulatory standards and internal policies.
• Oversee physical records collections managed in local onsite CDGM archives and offsite storage.
• Ensure the archiving service for both paper and electronic records is delivered in compliance with applicable regulations and the Sponsor's policies, adhering to agreed SLAs to meet business requirements.
• Act as the subject matter expert on archiving, supporting CDGM, and business-driven projects and activities related to archive systems, processes, and archived records.
• Provide audit and inspection readiness support in relation to archiving, contributing to root cause analysis, and the identification and creation/delivery of corrective and preventative actions (CAPAs).
• Develop and maintain archiving training materials, overseeing both formal and informal processes and tracking tools for electronic and physical clinical records.
• Execute vendor oversight plans concerning archive staff and other third parties, monitoring service metrics, and identifying opportunities for operational improvements. Serve as the point of escalation for any issues.
• Identify and implement enhancements to archive operations and services.
• May lead innovation projects aimed at enhancing archiving services.

Ideal Background

• Bachelor’s degree or equivalent, along with relevant industry experience.
• A minimum of 3-4 years of experience in clinical research and development within the pharmaceutical industry and/or Contract Research Organizations, with specific expertise in clinical documentation and/or records and information management.
• Strong influencing and presentation skills, with the ability to communicate effectively at all levels.
• High organizational awareness, demonstrated experience in multi-disciplinary teams, and the ability to navigate diverse cultures and geographies.
• Proficient in negotiation, problem-solving, and conflict resolution, 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.