Clinical Trial Manager – APAC

🔥 0 minutes ago

🇦🇺 Australia – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

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Worldwide Clinical Trials

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Worldwide Clinical Trials is a global contract research organization (CRO) that provides comprehensive clinical trial services. They specialize in supporting studies across diverse therapeutic areas such as oncology, cardiology, and rare diseases. With over 30 years of experience, Worldwide Clinical Trials emphasizes personalized support and customized solutions throughout the entire lifecycle of drug development. Their services include clinical monitoring, data management, patient recruitment, and regulatory consulting, ensuring precision and tailored attention for each clinical trial.

📋 Description

• Lead and coordinate site management and monitoring activities across clinical studies from initiation through close-out • Partner with Project Management to establish monitoring strategies, operational targets, and study execution plans aligned with project goals • Provide leadership, guidance, and clinical expertise to Clinical Research Associates and site management team members throughout the study lifecycle • Serve as the primary site management representative for sponsors, investigators, study teams, audits, inspections, and key project meetings • Oversee monitoring quality, site performance, protocol compliance, and timely completion of monitoring deliverables • Drive patient recruitment efforts, monitor enrollment performance, and support site-level strategies to keep recruitment on target • Review study metrics, trends, and analytics to improve site performance, data quality, and operational effectiveness • Identify, escalate, and help resolve study risks and site issues while implementing proactive mitigation strategies • Ensure Trial Master File compliance, inspection readiness, and adherence to study protocols, SOPs, regulatory requirements, and quality standards • Collaborate with global teams across multiple time zones • Travel as required

🎯 Requirements

• Bachelor's degree (or equivalent) in biological, physical, health, nursing, life sciences, or a related field, with relevant clinical research experience; alternatively, a two-year degree with extensive Senior Clinical Research Associate experience • Minimum 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 supporting or functioning as a Clinical Trial Manager, Lead CRA, or equivalent role • Strong leadership experience guiding, motivating, and supporting remote clinical teams • Extensive knowledge of clinical research processes, monitoring practices, Good Clinical Practice (GCP), ICH Guidelines, FDA and/or EU regulations, and local regulatory requirements • Experience developing and implementing monitoring strategies, overseeing site performance, and managing clinical operations deliverables • Proficiency with Microsoft Office and clinical systems including EDC, CTMS, eCRF, IVRS, and IxRS platforms • Excellent planning, organizational, presentation, communication, negotiation, problem-solving, and stakeholder management skills • Proficiency in English • Must be based in Australia • Valid passport and driver's license required

🏖️ Benefits

• Collaborative and inclusive work environment • Growth and career development opportunities • Opportunity to learn and contribute to clinical research • Remote work arrangement • Global team collaboration • Travel opportunities as part of the role

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