Job Overview
The GCP Archivist will be responsible for delivering archiving services for electronic and paper clinical trial-related records in compliance with appropriate regulations while meeting the business needs of the Sponsor.
Location
Office-based in Basel, Switzerland
Essential Functions
- Serve as the Archivist, managing 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.
- Oversee physical records collections managed in local onsite CDGM archives and offsite storage.
- Deliver archiving services for paper and electronic records in accordance with appropriate regulations and Sponsor policies, adhering to agreed SLAs to meet business needs.
- Act as a subject matter expert on archiving, supporting CDGM initiatives and business-driven projects related to archive systems, processes, and archived records.
- Provide audit and inspection readiness support pertaining to archiving and contribute to root cause analysis, identifying and developing corrective and preventive actions (CAPAs).
- Serve as a Subject Matter Expert for archiving training materials, formal and informal processes, and tracking tools for electronic and physical clinical records.
- Execute vendor oversight plans regarding archive staff and third parties, monitor service metrics, and identify opportunities for operational improvements. Act as the point of escalation for any issues.
- Identify and implement enhancements 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 relevant industry experience.
- A minimum of 3 to 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 management.
- Strong influencing and presentation skills, with the ability to communicate effectively at all organizational levels.
- High organizational awareness, including experience working in multi-disciplinary teams across diverse cultures and geographies.
- Excellent negotiation, problem-solving, and conflict resolution skills, with a proven track record of establishing trusted relationships with internal and external stakeholders.
Apply online using the form below. Only applications matching the job profile will be considered.