Clinical Trial Manager

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

📋 Description

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

• Ensure that studies adhere to protocols, standard operating procedures (SOPs), ICH-GCP guidelines, and relevant regulatory requirements.

• Serve as the main clinical contact for clients.

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

• Create clinical documents including study plans, informed consent forms, study materials, manuals, CRF completion guidelines, trackers, presentation slides, and training resources.

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

• Generate site lists and oversee site feasibility processes.

• Evaluate enrollment risks and devise strategies for country recruitment and retention.

• Coordinate feasibility assessments, site start-up, enrollment processes, maintenance, and close-out operations.

• Lead internal clinical team meetings and establish expectations for CRAs and Clinical Trial Assistants (CTAs).

• Address inquiries from CRAs and sites and maintain logs of frequently asked questions (FAQs).

• Provide support for investigator meetings.

• Review or approve investigational product release packages.

• Manage submissions and approvals to Competent Authorities and Institutional Review Boards (IRB)/Ethics Committees.

• Develop strategies for clinical monitoring while ensuring adherence to timelines and quality deliverables.

• Utilize metrics from Clinical Trial Management Systems (CTMS), analyze data management query trends, and monitor outstanding reports.

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

• Collaborate with Project Managers, CRAs, and Quality Assurance (QA) teams on the development, implementation, and closure of Corrective and Preventive Actions (CAPA).

• Assist sites, internal personnel, and CRAs in preparing for Good Clinical Practice (GCP) audits.

• Address project resource challenges and escalate issues related to CRA performance or site compliance.

• Work with data management and CRAs to ensure data integrity and expedite data cleaning processes.

• Oversee the accountability and reconciliation of investigational products.

• Undertake project management responsibilities in the absence of a dedicated cross-functional Project Manager.

• Support business development and marketing initiatives.

• May negotiate site budgets and investigator contracts.

• May review site visit reports and the execution of monitoring plans.

• May manage clinical vendors.

• May conduct clinical data reviews and generate queries.

• May have supervisory responsibilities and manage the workload of supervised staff.

• Perform additional duties as assigned by management.

⛳️ Requirements

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

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

• Experience in Phase 1, First in Human (FIH) clinical trials involving health volunteers.

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

• Familiarity with Microsoft Office applications: Outlook, Word, Excel, and PowerPoint.

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

• Exceptional organizational abilities, meticulous attention to detail, and a customer service-oriented attitude.

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

🏝️ Benefits

• Opportunity to work remotely from Australia.

• Regular full-time employment.

• Chance to engage with cutting-edge technologies, scientific expertise, laboratory skills, and advanced data sciences.

• Focus on oncology and rare diseases.

• Equal Opportunity Employer.

• Reasonable accommodations available for applicants with disabilities.