Clinical Trial Coordinator – FSP, client dedicated

• Coordinate, oversee, and complete assigned clinical trial activities according to the task matrix
• Perform department, internal, country, and investigator file reviews and document findings
• Ensure allocated tasks are completed on time, within budget, and to quality standards
• Communicate project risks to project leads and line manager
• Maintain study documentation, team lists, training trackers, system access, and project activity plans
• Keep the electronic Trial Master File up to date and provide eTMF and GoBalto system support
• Support risk-based monitoring activities
• Process trial documents, perform eTMF reviews, conduct mass mailings, and provide reports
• Schedule and organize client and internal meetings and prepare meeting minutes
• Review and track local regulatory documents
• Transmit documents to the client and centralized IRB/IEC
• Analyze and reconcile study metrics and findings reports
• Assist with clarification and resolution of site documentation findings
• Maintain vendor trackers
• Coordinate, compile, and distribute Investigator Site File and Pharmacy binder materials and non-clinical study supplies
• Assist with study-specific translation materials and translation quality control
• Attend kick-off meetings and take notes when required
• Serve as a study lead or cross-functional liaison as needed
• Buddy and train new staff during onboarding
• Support departmental and cross-functional process improvement initiatives

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
• Previous experience providing the knowledge, skills, and abilities to perform the job, comparable to at least 4 years
• Equivalency may be met through a combination of appropriate education, training and/or directly related experience
• Ability to work in a team or independently as required
• Strong organizational skills and attention to detail, with ability to handle multiple tasks efficiently and effectively
• Ability to analyze project-specific data/systems to ensure accuracy and efficiency
• Strong customer focus
• Flexibility and adaptability to reprioritize workload and meet changing project timelines
• Working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs
• Excellent Dutch and English language and grammar skills; French ideally
• Good presentation skills
• Excellent computer skills; proficiency in MS Office (Word, Excel, and PowerPoint)
• Ability to obtain knowledge and master clinical trial database systems
• Ability to successfully complete PPD clinical training program
• Self-motivated, positive attitude with effective interpersonal skills
• Occasional drives to site locations and potential occasional travel required

• Fully remote work arrangement
• Standard Monday–Friday work schedule