Senior Documentation Specialist

Job description

About this position As 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. Your tasks: Oversee 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. Perform 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. Plan and conduct risk-based periodic oversight reviews of CRO and laboratory TMFs; identify quality or completeness issues, recommend remediation actions, monitor progress and escalate significant or recurring risks. Lead 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. Act 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. Analyse and communicate TMF quality and performance metrics, identify trends and recommend improvements to processes, systems, templates and ways of working. Ensure assigned activities comply with company and CRO SOPs, ICH GCP, applicable regulations and relevant regulatory guidance. Represent Clinical Documentation in study meetings, provide input on TMF status and quality, and follow up on agreed documentation actions, decisions and risks. Prepare and deliver TMF guidance and training, and share expertise with study-team members and other TMF colleagues on compliant documentation practices. Role requirements Bachel…