Regional Clinical Trial Management Associate

• Support the Regional Clinical Study Manager in regional study delivery, ensuring delegated clinical study components meet quality, timeline, and budget expectations
• Support feasibility assessment, study start-up, document generation and review, sample tracking, and participant enrollment
• Interpret and implement clinical research regulations and ICH guidelines
• Support regional team meeting setup and logistics
• Collaborate with the Regional Clinical Study Manager, Global Study Management Associate, CRAs, and regional and global stakeholders
• Prepare monitoring visit materials and file documents in the TMF
• Create and maintain regional/country SharePoint folders and study distribution lists
• Set up and maintain countries and sites in eTMF, CTMS, and other systems
• Support system access requests and user account management
• Assist with local adaptation and review of study-related documents
• Support regional/country study start-up and investigator meetings
• Create, maintain, review, and quality-check country/site-level TMF documents
• Resolve regional/country clinical supply issues with stakeholders
• Support data cleaning and follow-up of outstanding information
• Prepare site newsletters and study correspondence
• Assist with routine study questions from clinical trial sites
• Support maintenance of regional/country information in public registries such as CT.gov
• Provide regional/country information for Clinical Study Reports
• Support operational risk identification, quality assurance audits, inspections, process improvements, local/regional tools, work instructions, and SOPs
• Support regional vendor setup and regional study budget and purchase order management

• Bachelor’s Degree in a scientific or healthcare discipline required
• Higher Degree preferred
• Exceptions might be made for candidates with relevant clinical operations experience
• MS Office
• Knowledge of clinical operations methodologies and understanding of operational aspects of clinical study processes
• 1 or more years of experience in clinical research within biotech, pharma or CRO industry
• Limited travel might be required