GCP Archivist

Overview of Responsibilities

The incumbent will play a pivotal role in ensuring the effective management and archiving of electronic and paper clinical trial-related records, adhering to relevant regulations to fulfill the business objectives of the Sponsor.

Key Responsibilities

• Act as the primary Archivist, overseeing the management of archived records across various platforms.
• Collaborate with both business and technical stakeholders to maintain compliance with regulatory standards and internal policies.
• Oversee the physical records collections maintained in local onsite CDGM archives as well as in offsite storage.
• Ensure the archiving of paper and electronic records meets regulatory requirements and the Sponsor's policies, fulfilling agreed service level agreements (SLAs) to address business needs.
• Serve as an Archiving subject matter expert, supporting CDGM and business-driven projects related to archive systems, processes, and records management.
• Provide audit and inspection readiness support regarding archiving practices; contribute to root cause analysis and develop corrective and preventative actions (CAPAs).
• Develop and facilitate training materials regarding archiving processes for electronic and physical clinical records.
• Execute vendor oversight plans for archive personnel and third-party service providers; monitor service metrics and identify operational improvement opportunities.
• Act as the escalation point for resolving issues and challenges encountered within archive operations.
• Propose and implement enhancements to archiving operations and services.
• Potentially lead innovation projects aimed at advancing archive services.

Qualifications

• Bachelor’s degree or equivalent with relevant industry experience.
• Three to four years of experience in clinical research and development within the pharmaceutical industry or Contract Research Organizations, focusing on clinical documentation and records management.
• Demonstrated strong influencing and presentation skills with effective communication across various organizational levels.
• High organizational awareness and experience working within multi-disciplinary teams across diverse cultures and geographies.
• Proficient in negotiation, problem-solving, and conflict resolution, exhibiting an ability to establish trusted relationships with both internal and external stakeholders.