Clinical Trial Manager

• Serve as 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
• Collaborate with the Project Manager on monthly invoicing and clinical budget variance management
• Develop clinical study documents, plans, forms, manuals, guidelines, trackers, slides, and training materials
• Identify training needs for CRAs and third-party vendors and present training at investigator and study kick-off meetings
• Generate potential site lists and drive site feasibility
• Identify enrollment risks and develop country recruitment and retention strategies
• Manage communication and relationships with investigators and study teams throughout feasibility, start-up, enrollment, maintenance, and closeout
• Lead internal clinical team meetings and set expectations for CRAs and CTAs
• Address CRA and site questions and maintain FAQ logs
• Support investigator meetings
• 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 metrics reporting, including CTMS, DM query trends, and outstanding monitoring reports
• Implement and manage the eTMF
• Collaborate with PM, CRAs, and QA on CAPA development, implementation, and closure
• Support GCP audit preparation
• Address 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 a cross-functional PM is not 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
• May perform clinical data review and query generation
• May have line management responsibilities and manage supervised staff workload
• 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 proficient required to support Mandarin-speaking clients
• Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint)
• Excellent communication and interpersonal skills
• Excellent organizational skills and attention to detail
• 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

• Regular full-time employment
• Remote work arrangement in Australia, Singapore, or South Korea
• Equal opportunity employment
• Reasonable accommodation for applicants with disabilities