Senior Documentation Specialist

h3About this position /h3pAs the Senior Documentation Specialist, you ensure the effective management, quality, completeness, and inspection readiness of essential clinical trial documentation for assigned studies, programmes or documentation activities, including the sponsor TMF and oversight of CRO and laboratory TMFs. You acts as an experienced TMF specialist, working closely with Clinical Operations and cross-functional study teams to provide expert guidance on document processes, compliance, risk management and continuous improvement. /ppbYour tasks: /b /pullipOversee documentation handling, filing and archival activities for assigned studies, programmes or documentation activities across relevant functional areas, ensuring that final documents are complete, accurate, traceable and maintained in the company document management system. /p /lilipPerform complex quality-control reviews and provide technical oversight of QC activities completed by TMF colleagues and external partners, in accordance with applicable SOPs, the CDISC TMF Reference Model, study-specific TMF Plans and regulatory requirements. /p /lilipPlan and conduct risk-based periodic oversight reviews of CRO and laboratory TMFs; identify quality or completeness issues, recommend remediation actions, monitor progress and escape significant or recurring risks. /p /lilipLead TMF inspection-readiness activities for assigned studies and coordinate documentation support during audits and regulatory inspections; develop and coordinate documentation-related corrective and preventive actions, monitor implementation and verify effective closure. /p /lilipAct as a TMF subject matter expert for study teams and external partners, providing practical guidance and escalating matters that require management direction or cross-functional decisions. /p /lilipAnalyse and communicate TMF quality and performance metrics, identify trends and recommend improvements to processes, systems, templates and ways of working. /p /lilipEnsure assigned activities comply with company and CRO SOPs, ICH GCP, applicable regulations and relevant regulatory guidance. /p /lilipRepresent Clinical Documentation in study meetings, provide input on TMF status and quality, and follow up on agreed documentation actions, decisions and risks. /p /lilipPrepare and deliver TMF guidance and training, and share expertise with study-team members and other TMF colleagues on compliant documentation practices. /p /li /ulh3Role requirements /h3ullipBachelor’s degree in a scientific, health-related or other relevant discipline. /p /lilipMinimum seven years of experience in TMF and documentation management within the pharmaceutical or CRO industry, including at least three years of experience in biotechnology or another fast-growing, dynamic environment. /p /lilipAdvanced knowledge of eTMF solutions, such as Veeva Vault Clinical, PhlexTMF or comparable platforms, together with strong working knowledge of ICH GCP, applicable regulations and the CDISC TMF Reference Model. /p /lilipDemonstrated experience in TMF quality control, risk-based TMF reviews and CRO or vendor oversight. /p /lilipDemonstrated experience leading TMF inspection-readiness activities and managing documentation-related findings and corrective and preventive actions. /p /lilipStrong stakeholder-management and communication skills, with the ability to provide clear guidance, influence without direct authority and build effective working relationships across functions. /p /lilipProactive and accountable approach, with sound judgement, analytical problem-solving skills and the ability to identify and implement pragmatic, GCP-compliant solutions. /p /lilipExcellent attention to detail, organisation and time management, with the ability to prioritise and manage multiple activities in a dynamic environment. /p /lilipProfessional proficiency in written and spoken English. /p /li /ulh3Work permit /h3pCandidate needs to hold a Swiss work permit or be an EU citizen eligible to work in Switzerland /p #J-18808-Ljbffr