Clinical Trial Coordinator

• Assist in coordinating and administering clinical studies from start-up through execution and close-out
• Collect, prepare, review, track, and submit study documents to EC/IRB and regulatory authorities
• Interface with investigators, external service providers, CRAs, Data Management, and Global Clinical Solutions representatives
• Serve as the local administrative main contact and work with CRAs and/or LSAD throughout the study
• Set up and maintain the local eTMF and ISF in accordance with ICH-GCP and local requirements
• Upload essential documents promptly to maintain eTMF inspection readiness
• Prepare documents for final archiving and support ISF close-out activities
• Produce and maintain study documents, ensuring template and version compliance
• Create or import clinical-regulatory documents into the Global Electronic Management System
• Support electronic applications and submissions using Submission Ready Standards
• Set up and maintain information in CTMS, SharePoint, and other tracking and communication tools
• Prepare or support site-level contracts and HCO/HCP payments
• 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
• Prepare and distribute presentation materials, newsletters, websites, letters, and meeting minutes
• Perform layout and language control, copying, document distribution, translation, spell checks, and email archiving
• Ensure compliance with company ethics, policies, procedures, legislation, and safety requirements

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
• Bachelor's degree preferred
• Previous experience providing the knowledge, skills, and abilities to perform the job (comparable +2 years)
• Ability to work in a team or independently
• Good organizational skills and strong attention to detail
• Ability to handle multiple tasks efficiently and effectively
• Ability to analyze project-specific data/systems for accuracy and efficiency
• Strong customer focus
• Flexibility to reprioritize workload for changing project timelines
• Working knowledge of applicable country regulations, ICH Good Clinical Practices, and organization/client SOPs and WPDs
• Good English language and grammar skills and proficient local language skills as needed
• Proficiency in MS Office (Word, Excel, and PowerPoint)
• Ability to learn and master clinical trial database systems
• Ability to successfully complete the organization's clinical training program
• Self-motivated, positive attitude, and good interpersonal skills
• Effective oral and written communication skills
• Essential judgment and decision-making skills
• Ability to accurately follow project work instructions
• Good negotiation skills
• Independent thinking
• Ability to manage risk and perform risk escalation appropriately
• Occasional drives to site locations

• Potential occasional travel required
• Clinical training program
• Remote work arrangement
• Standard Monday–Friday work schedule