Clinical Study Administrator – CTA

• Assist in coordination and administration of clinical studies from start-up through execution and closeout
• Serve as the local administrative main contact and work with CRAs and/or the Local Study Associate Director
• Set up, populate, and maintain client tracking and communication systems such as CTMS, VCV, and SharePoint
• Coordinate and track study materials and equipment
• Coordinate administrative tasks during studies, audits, and regulatory inspections
• Lead practical arrangements and support preparation of internal and external meetings
• Liaise with internal and external participants and vendors
• Prepare, contribute to, and distribute presentation materials for meetings, newsletters, and websites
• Interface with investigators, external service providers, CRAs, data management, and global clinical solutions representatives
• Maintain the local electronic Trial Master File and Investigator Site File, including document tracking
• Upload essential documents promptly to maintain eTMF inspection readiness
• Prepare study documents for final archiving and support CRA closeout activities
• Produce and maintain study documents with template and version compliance
• Manage document layout, language control, copying, printing, distribution, and email archiving
• Collect, prepare, review, and track documents for regulatory applications
• Assist with submissions to EC/IRB and Regulatory Authorities
• Create or import clinical-regulatory documents into global electronic management systems
• Support electronic applications and submissions according to Submission Ready Standards
• Prepare or support site-level contracts
• Prepare, support, or perform HCO/HCP payments in accordance with local regulations

• Knowledge of ICH-GCP and local requirements
• Ability to work with clinical trial management systems and electronic management systems, including CTMS, SharePoint, VCV, and ANGEL
• Ability to handle clinical-regulatory documents according to technical standards, including Submission Ready Standards (SRS)
• Ability to support EC/IRB and Regulatory Authority submissions
• Ability to perform document collection, tracking, maintenance, archiving, and version control
• Ability to support site-level contracts and HCO/HCP payments in accordance with local regulations
• English and local-language translation and spell-checking capability, as required