Clinical Trial Manager – APAC

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

📋 Description

• Lead and manage site oversight and monitoring activities for clinical studies from the initiation phase to close-out.

• Collaborate with Project Management to define monitoring strategies, operational objectives, and study execution plans that align with project goals.

• Provide leadership, direction, and clinical knowledge to Clinical Research Associates and site management team members throughout the study lifecycle.

• Act as the main site management representative for sponsors, investigators, study teams, audits, inspections, and significant project meetings.

• Supervise monitoring quality, site performance, protocol adherence, and the timely completion of monitoring deliverables.

• Drive efforts for patient recruitment, assess enrollment performance, and support site-level strategies to maintain recruitment targets.

• Analyze study metrics, trends, and analytics to enhance site performance, data integrity, and operational efficiency.

• Identify, escalate, and assist in resolving study risks and site-related issues while implementing proactive mitigation strategies.

• Ensure compliance with the Trial Master File, readiness for inspections, and adherence to study protocols, SOPs, regulatory standards, and quality benchmarks.

• Collaborate with global teams across various time zones.

• Travel as necessary.

⛳️ Requirements

• A Bachelor's degree (or equivalent) in biological, physical, health, nursing, life sciences, or a related discipline, along with relevant clinical research experience; alternatively, a two-year degree with significant Senior Clinical Research Associate experience.

• A minimum of three years of experience as a Senior Clinical Research Associate (or equivalent), or five years with a two-year degree.

• At least six months of experience in a supporting or leading role as a Clinical Trial Manager, Lead CRA, or equivalent position.

• Strong leadership experience in guiding, motivating, and supporting remote clinical teams.

• In-depth knowledge of clinical research methodologies, monitoring practices, Good Clinical Practice (GCP), ICH Guidelines, FDA and/or EU regulations, and local regulatory requirements.

• Experience in developing and executing monitoring strategies, overseeing site performance, and managing clinical operations deliverables.

• Proficient in Microsoft Office and clinical systems, including EDC, CTMS, eCRF, IVRS, and IxRS platforms.

• Exceptional planning, organizational, presentation, communication, negotiation, problem-solving, and stakeholder management abilities.

• Proficiency in English.

• Must reside in Australia.

• A valid passport and driver's license are required.

🏝️ Benefits

• A collaborative and inclusive workplace culture.

• Opportunities for growth and career advancement.

• A chance to learn and contribute to the field of clinical research.

• Flexible remote work arrangements.

• Opportunities for global team collaboration.

• Travel opportunities as part of the role.