Principal Clinical Trial Coordinator

• Provide administrative and technical support to project teams as a study lead and cross-functional liaison
• Coordinate, facilitate, and oversee assigned clinical trial project activities
• Perform department, internal, country, and investigator file reviews and document findings
• Ensure allocated tasks are completed on time, within budget, and to quality standards
• Maintain study documentation, project trackers, team lists, training requirements, system access, and activity plans
• Keep the electronic Trial Master File current and support risk-based monitoring activities
• Process documents, distribute communications, provide reports, and organize client/internal meetings and minutes
• Review and track local regulatory documents and support audit readiness and audit responses
• Transmit documents to clients and centralized IRB/IEC
• Analyze and reconcile study metrics and findings; resolve site documentation findings
• Maintain vendor trackers and coordinate Investigator Site File, pharmacy binder, and study supply materials
• Support translation materials and translation quality control
• Provide system support for Activate and eTMF and maintain current databases
• Liaise locally on submission activity in accordance with global submission strategy
• Train new personnel and other functional team members, investigators, and clients as requested
• Serve as an alliance-level lead for client integration and eTMF activities
• Support site activation targets, including site agreements, budgets, essential documents, regulatory packages, and site-specific documents
• Develop site lists, maintain investigator/site contact details, and complete Site Interest Plans in CTMS
• Conduct site contact, follow-up, surveys, phone interviews, and feasibility activities
• Coordinate with Global Investigator Services and contribute to global feasibility processes and best practices
• Recommend new sites using local market knowledge and serve as a subject matter expert on feasibility survey tools

• 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 6 years
• A combination of appropriate education, training and/or directly related experience may be considered sufficient
• Excellent 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
• Knowledge of applicable country regulations, ICH Good Clinical Practices, organization/client SOPs and WPDs
• Effective presentation, oral and written communication, negotiation, and problem-solving skills
• Basic medical/therapeutic area and medical terminology knowledge
• Basic knowledge of local health systems
• Ability to work in a matrix environment and manage risk appropriately
• Occasional drives to site locations; potential occasional travel required

• Fully remote work arrangement
• Standard Monday–Friday work schedule
• Professional training and onboarding support
• Training opportunities and knowledge development
• Potential occasional travel to site locations