Clinical Trial Manager
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Job Description
Clinical Trial Manager leading operational execution of oncology and rare-disease studies at Precision for Medicine, a life-sciences CRO. Managing sites, clinical teams, compliance, recruitment, and trial data quality.
Responsibilities:
- 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 the primary clinical point of contact with the client
- Collaborate with the Project Manager on monthly invoicing and clinical budget variance management
- Develop clinical documents, study plans, informed consent templates, study forms, manuals, CRF completion 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 site lists and lead site feasibility processes
- Assess enrollment risks and develop country recruitment and retention strategies
- Coordinate feasibility, site start-up, enrollment, maintenance, and close-out activities
- 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 ensure timelines and quality deliverables
- Generate and use metrics from CTMS, data-management query trends, and outstanding monitoring reports
- Implement and manage the eTMF
- Collaborate with PM, CRAs, and QA on CAPA development, implementation, and closure
- Assist sites, internal staff, and CRAs with GCP audit preparation
- Address project resourcing issues and escalate CRA performance or site compliance issues
- Collaborate with data management and CRAs to ensure data quality and timely data cleaning
- 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-plan 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
Requirements:
- Bachelor’s degree or equivalent combination of education/experience in science or health-related field
- 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 health-volunteer clinical trials
- Mandarin language proficiency required to support Mandarin-speaking clients
- Experience with Microsoft Office products: Outlook, Word, Excel, and PowerPoint
- Excellent communication and interpersonal skills to effectively interface with others in a team setting
- Excellent organizational skills, attention to detail, and customer service demeanor
- Ability to travel domestically and internationally, including overnight stays
Benefits:
- Ability to work remotely in Australia
- Regular full-time employment
- Opportunity to work with new technologies, scientific expertise, laboratory expertise, and advanced data sciences
- Focus on oncology and rare disease
- Equal Opportunity Employer
- Reasonable accommodation available for applicants with disabilities
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