Clinical Trial Manager
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Job Description
Clinical Trial Manager leading clinical study operations for a CRO integrating scientific, laboratory, and data-science expertise. Managing monitoring, sites, regulatory submissions, and trial delivery in Australia.
Responsibilities:
- Serve as the clinical trial lead responsible for planning, conduct, and oversight of the operational portion of clinical studies
- Ensure studies comply with protocols, SOPs, ICH-GCP, and applicable regulatory requirements
- Act as the primary clinical point of contact with the client
- Collaborate with the Project Manager on monthly invoicing and clinical budget variance management
- Develop study-related clinical documents, plans, forms, manuals, 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
- 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 metrics to meet timelines and quality requirements
- Implement and manage the eTMF
- Develop and implement CAPA plans with the Project Manager, CRAs, and QA
- Assist sites, internal staff, and CRAs with GCP audit preparation
- Manage resourcing issues, escalate CRA performance and site compliance issues, and ensure data quality
- Manage investigational product processes, including drug accountability and reconciliation
- Assume project management responsibilities when a cross-functional Project Manager is not assigned
- Support business development and marketing activities
- Potentially negotiate site budgets and investigator contracts, manage clinical vendors, review site visit reports, perform clinical data review, and manage supervised staff workloads
- Perform other duties assigned by management
Requirements:
- 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
Benefits:
- Regular full-time employment
- Ability to travel domestically and internationally, including overnight stays
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