Clinical Trial Manager

This is a fully remote position, open to applicants in Australia.

📋 Description

• Act as the clinical trial lead, accountable for the planning, execution, and oversight of the operational aspects of clinical studies.

• Ensure that studies adhere to protocols, SOPs, ICH-GCP, and relevant regulatory standards.

• Serve as the primary clinical liaison with the client.

• Collaborate with the Project Manager on monthly invoicing and management of clinical budget variances.

• Create study-related clinical documents, plans, forms, manuals, trackers, slides, and training materials.

• Identify training requirements for CRAs and third-party vendors, and deliver training during Investigator and Study Kick-off meetings.

• Generate lists of potential sites and facilitate site feasibility assessments.

• Develop strategies for country-specific recruitment and retention.

• Coordinate feasibility, site initiation, enrollment, ongoing maintenance, and close-out processes.

• Lead internal clinical team meetings and establish expectations for CRAs and CTAs.

• Address inquiries from CRAs and sites, while maintaining FAQ logs.

• Support investigator meetings and review or approve investigational product release packages.

• Oversee submissions and approvals to Competent Authorities and IRB/Ethics Committees.

• Formulate clinical monitoring strategies and track study metrics to ensure adherence to timelines and quality standards.

• Implement and manage the electronic Trial Master File (eTMF).

• Develop and execute CAPA plans in collaboration with the Project Manager, CRAs, and QA.

• Assist sites, internal personnel, and CRAs in preparing for GCP audits.

• Manage resource-related issues, escalate CRA performance and site compliance concerns, and ensure data integrity.

• Oversee processes related to investigational products, including drug accountability and reconciliation.

• Assume project management responsibilities when a cross-functional Project Manager is unavailable.

• Support business development and marketing initiatives.

• Potentially negotiate site budgets and investigator contracts, manage clinical vendors, review site visit reports, conduct clinical data reviews, and oversee staff workloads.

• Carry out other tasks as assigned by management.

⛳️ Requirements

• Bachelor’s degree or an equivalent combination of education and experience in a science or health-related field; advanced degree is preferred.

• At least 5–8 years of clinical research experience or demonstrated competencies for the role, with substantial clinical monitoring experience.

• Experience in Phase 1 First-in-Human (FIH) and healthy volunteer clinical trials.

• Proficiency in Mandarin is required to support Mandarin-speaking clients.

• Familiarity with Microsoft Office Suite (Outlook, Word, Excel, PowerPoint).

• Strong communication and interpersonal skills to effectively collaborate with team members.

• Exceptional organizational abilities, attention to detail, and a customer-oriented approach.

• Willingness to travel domestically and internationally, including overnight stays.

🏝️ Benefits

• Regular full-time employment.

• Opportunity for domestic and international travel, including overnight stays.