Clinical Trial Coordinator II

• Provide administrative and technical support to the Project Team
• Support audit readiness through scheduled file reviews and documentation of findings
• Provide administrative support for site activation and help develop site activation critical paths
• Conduct feasibility assessments and develop local site knowledge bases
• Develop and review site lists for feasibility activities and site tiering
• Coordinate, oversee, and complete assigned trial activities according to the task matrix
• Review department, internal, country, and investigator files
• Perform assigned trial administration, including document processing, eTMF reviews, mass mailings, and reports
• Review and track local regulatory documents
• Analyze and reconcile study metrics and findings reports
• Maintain vendor trackers and study-specific documentation
• Coordinate Investigator Site File and Pharmacy binder materials and supplies
• Support translation materials and translation quality control
• Provide technical and administrative project support with internal departments
• Maintain trial status information in databases
• Maintain client local affiliate relationships where applicable
• Conduct on-site feasibility visits where applicable (Asia Pacific only)
• Train new personnel in processes and systems
• Support study systems, tools, trackers, RBM activities, document transmissions, meetings, and meeting minutes
• Coordinate with internal departments to align site start-up activities with the critical path
• Assist with regulatory compliance review packages and regulatory submissions
• Obtain site-selection documents and maintain investigator/site contact details
• Complete Site Interest Plans, document site communications, and review survey data
• Communicate site issues and risks and escalate concerns or non-compliance
• Conduct phone interviews with physicians and site personnel for trial optimization
• Liaise with Global Investigator Services to resolve investigator queries
• Contribute to global strategic feasibility processes and best practices

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
• Previous experience comparable to at least 2 years
• Bachelor's degree preferred
• Ability to work in a team or independently
• Strong organizational skills and attention to detail
• Ability to handle multiple tasks efficiently and effectively
• Ability to analyze project-specific data/systems
• Strong customer focus
• Flexibility and adaptability to changing project timelines
• Working knowledge of applicable country regulations, ICH Good Clinical Practices, and organization/client SOPs and WPDs
• Excellent English language and grammar skills and proficient local language skills as needed
• Good presentation skills
• 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
• Effective oral and written communication skills with medical personnel
• Good negotiation skills
• Basic medical/therapeutic area and medical terminology knowledge
• Basic organizational and planning skills
• Basic knowledge of local health systems
• Working knowledge of GCP and applicable SOPs
• 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/site visits
• Professional training and onboarding support
• Opportunity to act as a buddy during onboarding
• Training and support for new personnel
• Participation in departmental process improvement initiatives