Senior Documentation Specialist

Overview

The Senior Documentation Specialist oversees the effective management, quality, completeness, and inspection readiness of essential clinical trial documentation for assigned studies, programmes, and documentation activities, including the sponsor Trial Master File and the oversight of contract research organization and laboratory Trial Master Files. The role involves working closely with Clinical Operations and cross-functional study teams to provide expert guidance on document processes, compliance, risk management, and continuous improvement.

Requirements

Applicants must hold a Bachelor’s degree in a scientific, health-related, or other relevant discipline, alongside a minimum of seven years of experience in Trial Master File and documentation management within the pharmaceutical or contract research organization industry. This experience must include at least three years in biotechnology or another fast-growing, dynamic environment. Candidates need advanced knowledge of electronic Trial Master File solutions such as Veeva Vault Clinical, PhlexTMF, or comparable platforms, alongside a strong working knowledge of International Council for Harmonisation Good Clinical Practice, applicable regulations, and the Clinical Data Interchange Standards Consortium Trial Master File Reference Model. Additional requirements include demonstrated experience in Trial Master File quality control, risk-based reviews, vendor oversight, leading inspection-readiness activities, and managing documentation-related findings alongside corrective and preventive actions. Professionals must also possess strong stakeholder-management and communication skills, a proactive and accountable approach, analytical problem-solving abilities, attention to detail, and professional proficiency in written and spoken English. Furthermore, candidates are required to hold a Swiss work permit or be European Union citizens eligible to work in Switzerland.