Clinical Trial Manager

This is a fully remote position, open to applicants in Australia, +2 more countries.

📋 Description

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

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

• Serve as the primary clinical liaison with the client.

• Create clinical study documents, plans, forms, manuals, trackers, presentation materials, and training resources.

• Identify training requirements for CRAs and third-party vendors and deliver training during investigator and study kick-off meetings.

• Generate site lists and facilitate site feasibility assessments.

• Formulate strategies for country recruitment and retention.

• Oversee feasibility assessments, site initiation, enrollment, maintenance, and study close-out processes.

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

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

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

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

• Develop strategies for clinical monitoring and track study timelines and deliverables.

• Utilize metric reporting to monitor study performance and communicate any issues.

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

• Create and execute CAPA plans in collaboration with PM, CRAs, and QA.

• Aid in GCP audit preparation.

• Coordinate project-specific resource issues with the PM.

• Escalate any issues related to CRA performance and site compliance.

• Work with data management and CRAs to ensure data quality and adherence to cleaning timelines.

• Manage accountability and reconciliation of investigational products.

• Assume project management duties in the absence of a cross-functional PM.

• Support business development and marketing initiatives.

• May negotiate site budgets and investigator contracts.

• May review site visit reports and monitoring activities.

• May manage clinical vendors and conduct clinical data reviews.

• May have line management and supervised-staff workload responsibilities.

• Carry out additional tasks as assigned by management.

⛳️ Requirements

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

• A minimum of 5-8 years of clinical research experience, demonstrating significant clinical monitoring capabilities.

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

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

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

• Exceptional communication and interpersonal skills to effectively collaborate in a team environment.

• Strong organizational skills, meticulous attention to detail, and a customer-focused approach.

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

• Candidates must be legally authorized to work in the country of employment without employer sponsorship.

🏝️ Benefits

• Competitive salary and performance-based incentives.

• Comprehensive health benefits including medical, dental, and vision coverage.

• Opportunities for professional development and career advancement.

• Flexible working arrangements to support work-life balance.

• A vibrant and inclusive company culture with a focus on teamwork and collaboration.