Clinical Trial Coordinator

• Coordinate and administer 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 and local study teams
• Serve as the local administrative contact 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 according to Submission Ready Standards
• Maintain CTMS, SharePoint and other tracking and communication systems
• Prepare or support site-level contracts
• Prepare, support or perform HCO/HCP payments in accordance with local regulations
• Coordinate and track study materials and equipment
• Coordinate administrative tasks during studies, audits and regulatory inspections
• Arrange and support internal and external meetings
• Prepare and distribute presentations, newsletters and website materials
• Perform layout, language control, copying and document distribution
• Support local translation and English/local-language spell checks
• Print and distribute letters and meeting minutes; handle and archive study emails
• Interface with data management teams to facilitate delivery of study documents and materials
• Ensure compliance with company ethics, policies, SOPs and applicable legislation

• 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)
• Equivalency through appropriate education, training and/or directly related experience may be considered
• Ability to work independently or in a team
• Strong organizational skills and attention to detail
• Ability to manage multiple tasks efficiently and effectively
• Ability to analyze project-specific data and systems for accuracy and efficiency
• Strong customer focus
• Flexibility to reprioritize workload
• Knowledge of applicable country regulations, ICH Good Clinical Practices, organization/client SOPs and WPDs
• Good English language and grammar skills and proficient local language skills as needed
• Proficiency in MS Office (Word, Excel, PowerPoint)
• Ability to learn and master clinical trial database systems
• Ability to complete the organization's clinical training program
• Effective oral and written communication skills
• Judgment and decision-making skills
• Ability to follow project work instructions accurately
• Negotiation skills
• Ability to manage risk and perform appropriate risk escalation
• Occasional drives to site locations and potential occasional travel

• Fully remote work mode
• Standard Monday–Friday work schedule
• Occasional travel opportunities