Senior Clinical Trial Manager

🕒 September 10

🌐 Australia, Japan – Remote

🇦🇺 Australia – Remote 🇯🇵 Japan – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 15%

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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 delivery of clinical study site management activities through coordination of clinical staff on complex studies • Ensure site qualification, initiation, interim monitoring, site management and study close-out activities comply with study protocols and plans • Provide leadership and direction to clinical site management team members from study start through closure • Oversee regional CTMs and coordinate efforts across the CTM team • Represent Site Management issues at sponsor, investigator and bid defense meetings • Contribute to project plans and formulate global monitoring strategies • Provide input to project tracking systems, financial performance reports, study metrics, resource allocation and time recognition • Collaborate with Business Development, Regulatory, Study Start-up and Project Management • Assume a dual PM/CTM role when needed • Develop, maintain and ensure compliance with Clinical Monitoring Plans, budgets, study tools and site visit reports • Train and manage CRA teams on clinical aspects of studies • Develop and implement recruitment strategies and track enrollment • Improve site data quality, review data metrics and address issues with action plans • Review data trends and trip report issues and escalate concerns • Oversee TMF compliance and inspection readiness • Forecast site visits and ensure staffing needs and backlogs are addressed • Set performance expectations and mentor or coach colleagues and clinical project staff • Perform co-monitoring and site visits as required • Support inspections by health authorities and sponsor audits • Proactively identify and mitigate risks • Perform other duties as assigned

🎯 Requirements

• Four-year college curriculum or equivalent with a major concentration in biological, physical or health studies, and a minimum of four years as a Senior Clinical Research Associate (or equivalent) • OR two-year college curriculum or equivalent education/training and a minimum of six years as a Senior Clinical Research Associate • Minimum 2 years relevant experience as a CTM/LCRA (or equivalent), including overseeing a CTM team • Travel required • Valid current passport required • Driving license required • Excellent oral and written communication skills in English • Strong understanding of FDA and/or EU Directive regulations, ICH Guidelines and local regulatory requirements • Proficient knowledge of Microsoft Office, eCRF and IVRS packages • Proficiency with IxRS, CTMS and EDC systems • Thorough understanding of clinical research principles and processes • Experience and understanding of therapeutic areas sufficient to function as CTM • Deep understanding of standard operating procedures • Excellent planning, organizational, interpersonal and presentation skills • Ability to lead and motivate teams remotely across time zones

🏖️ Benefits

• Diverse and inclusive work environment • Supportive and cohesive teams • Leadership accessibility • Equal employment opportunities • Mentoring and coaching opportunities