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 supervision of clinical studies.

• Ensure adherence to study protocols, Standard Operating Procedures (SOPs), ICH-GCP guidelines, and relevant regulatory requirements.

• Serve as the primary clinical liaison with the client.

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

• Create clinical study documents, plans, forms, manuals, guidelines, trackers, presentations, and training materials.

• Assess training needs for Clinical Research Associates (CRAs) and third-party vendors, delivering training at investigator and study kick-off meetings.

• Generate lists of potential sites and spearhead site feasibility efforts.

• Identify risks related to enrollment and devise strategies for country-specific recruitment and retention.

• Manage communication and foster relationships with investigators and study teams throughout the phases of feasibility, start-up, enrollment, maintenance, and closeout.

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

• Address inquiries from CRAs and sites while maintaining a log of frequently asked questions.

• Assist in the preparation of investigator meetings.

• Review or authorize investigational product release packages.

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

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

• Generate and utilize metrics reporting, including Clinical Trial Management System (CTMS), Data Management (DM) query trends, and outstanding monitoring reports.

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

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

• Support preparations for Good Clinical Practice (GCP) audits.

• Address project-specific resource challenges with the Project Manager.

• Escalate issues related to CRA performance and site compliance.

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

• Manage accountability and reconciliation of investigational products.

• Take on project management responsibilities in the absence of a cross-functional Project Manager.

• Support business development and marketing initiatives.

• May engage in negotiations regarding site budgets and investigator contracts.

• May review reports from site visits and assess monitoring execution.

• May oversee clinical vendors.

• May conduct clinical data reviews and generate queries.

• May hold line management responsibilities, overseeing the workload of supervised staff.

• Execute 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 preferred.

• A minimum of 5-8 years of experience in clinical research 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).

• Exceptional communication and interpersonal skills.

• Strong organizational skills and meticulous attention to detail.

• A customer service-oriented attitude.

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

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

🏝️ Benefits

• Regular full-time employment.

• Remote work opportunities available in Australia, Singapore, or South Korea.

• Commitment to equal opportunity employment.

• Reasonable accommodations for applicants with disabilities.