Clinical Trial Coordinator

• Provide administrative and technical support to project teams as a study lead and cross-functional liaison
• Coordinate and facilitate project activities and oversee administration on assigned projects
• Act as a buddy during onboarding and train new staff
• Identify training requirements and support departmental and cross-functional process improvement initiatives
• Develop critical paths for site activation and serve as a point of escalation for project teams
• Coordinate, oversee and complete assigned trial activities according to task matrices
• 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, systems, tools, trackers, study team lists, training requirements, access management and activity plans
• Support risk-based monitoring activities
• Process documents, perform eTMF reviews, distribute communications and provide reports
• Schedule and organize client/internal meetings and complete meeting 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 reports
• Maintain vendor trackers and current study databases
• Coordinate Investigator Site File and Pharmacy binder materials and non-clinical study supplies
• Support translation materials and translation quality control
• Liaise locally on regulatory submissions in accordance with global strategy
• Maintain accurate trial status information
• Conduct on-site feasibility visits where applicable in Asia Pacific
• Provide training to functional team members, investigators and clients
• Serve as an alliance-level lead for client integration and eTMF activities
• Support site activation, site agreements, budgets, essential documents and regulatory compliance packages
• Develop site lists, maintain investigator/site contact details and complete Site Interest Plans in CTMS
• Coordinate site contact, follow-up, survey data review and response goals
• Act as local expert on site capacity and experience and recommend additional sites
• Conduct phone interviews with physicians and site personnel regarding standard of care and protocol input
• Resolve investigator queries and maintain account/contact information
• Contribute to global feasibility processes, best practices and new-site identification
• Serve as subject matter expert on feasibility survey tools and future system releases

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
• Bachelor's degree preferred
• At least 6 years of previous experience providing the knowledge, skills, and abilities to perform the job
• Equivalent combination of appropriate education, training and/or directly related experience may be considered
• Ability to work independently or in a team
• Excellent organizational skills and attention to detail
• Ability to analyze project-specific data and systems
• Flexibility and adaptability to changing project timelines
• Knowledge of applicable country regulations, ICH Good Clinical Practices, organization/client SOPs and WPDs
• Excellent English language and grammar skills and proficient local language skills as needed
• Effective presentation skills
• Proficiency in MS Office (Word, Excel, PowerPoint) and ability to master clinical trial database systems
• Ability to successfully complete the organization's clinical training program
• Strong interpersonal, oral and written communication, problem-solving, negotiation and customer-focus skills
• Basic medical/therapeutic area and medical terminology knowledge
• Basic knowledge of local health systems
• Ability to work in a matrix environment
• Ability to manage risk and perform risk escalation appropriately

• Fully remote work mode
• Standard Monday–Friday work schedule
• Potential occasional travel
• Clinical training program
• Training and onboarding support