Clinical Trial Manager

• Serve as the clinical trial lead responsible for planning, conduct, and operational oversight of clinical studies
• Ensure studies comply with protocols, SOPs, ICH-GCP, and applicable regulatory requirements
• Act as primary clinical point of contact with the client
• Develop study clinical documents, plans, forms, manuals, trackers, presentation slides, and training materials
• Identify training needs for CRAs and third-party vendors and present training at investigator and study kick-off meetings
• Generate site lists and drive site feasibility processes
• Develop country recruitment and retention strategies
• Coordinate feasibility, site start-up, enrollment, maintenance, and close-out procedures
• Lead internal clinical team meetings and set expectations for CRAs and CTAs
• Address CRA and site questions and maintain FAQ logs
• Support investigator meetings and review or approve investigational product release packages
• Oversee submissions and approvals to Competent Authorities and IRB/Ethics Committees
• Develop clinical monitoring strategies and track study timelines and deliverables
• Generate and use metric reporting to monitor study performance and communicate issues
• Implement and manage the eTMF
• Develop and implement CAPA plans with PM, CRAs, and QA
• Support GCP audit preparation
• Coordinate project-specific resourcing issues with the PM
• Escalate CRA performance and site compliance issues
• Collaborate with data management and CRAs to ensure data quality and cleaning timelines
• Manage investigational product accountability and reconciliation
• Assume project management responsibilities when no cross-functional PM is assigned
• Support business development and marketing activities
• May negotiate site budgets and investigator contracts
• May review site visit reports and monitoring execution
• May manage clinical vendors and perform clinical data review
• May have line-management and supervised-staff workload responsibilities
• Perform other duties assigned by management

• Bachelor’s degree or equivalent combination of education/experience in science or health-related field; advanced degree preferred
• Minimum of 5-8 years of clinical research experience or proven competencies for the position with significant clinical monitoring experience
• Experience in Phase 1 FIH and healthy volunteer clinical trials
• Mandarin language proficiency required to support Mandarin-speaking clients
• Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint)
• Excellent communication and interpersonal skills to effectively interface with others in a team setting
• Excellent organizational skills, attention to detail, and a customer service demeanor
• Ability to travel domestically and internationally including overnight stays
• Candidates must be legally authorized to work in the country of employment without employer sponsorship