Clinical Trial Manager – Onco

🔥 1 minute ago

🇦🇺 Australia – Remote

⏰ Full Time

🟢 Junior

🧪 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 delivery of clinical study site management activities through coordination of Clinical staff within a geographic region • Ensure site qualification, initiation, interim monitoring, site management, and study close-out activities comply with study protocols, study plans, and Worldwide SOPs • Ensure quality and timeliness of clinical deliverables for assigned programs and/or regions • Collaborate with Project Management to set site management targets and monitoring strategy • Provide leadership and direction to clinical site management team members from study start through closure • Serve as the primary Site Management contact for clinical monitoring and site activities • Manage monitoring deliverables against study budget and identify out-of-scope activities • Customize and oversee study-specific Site Management Quality Management Documents, including Clinical Monitoring Plans • Oversee compliance with Clinical Monitoring Plans, site visits, trip reports, and visit follow-up letters • Review protocol deviations and visit action items • Train CRAs on clinical aspects of studies • Develop and implement patient recruitment strategies and track enrollment • Improve site data quality and address identified needs with action plans • Track and analyze Site Management deliverables, study metrics, financial performance, resource allocation, and trends • Oversee Trial Management File compliance and inspection readiness • Formulate regional monitoring strategy and forecast site visits and staffing needs • Review and finalize trip reports • Perform site qualification, initiation, interim monitoring, and close-out visits as needed • Solve problems and escalate monitoring and site issues with proposed solutions • Identify and mitigate risks • Represent Site Management as primary project contact when required • Conduct co-visits to ensure site, CRA, and study procedure quality • Perform other assigned duties

🎯 Requirements

• Excellent interpersonal, oral and written communication skills in English • Excellent planning, organizational, and time management skills • Excellent presentation skills • Flexibility to change • Ability to manage multiple and varied tasks with enthusiasm • Ability to negotiate and influence with diplomacy • Initiative and problem-solving skills • Ability to prioritize tasks, plan proactively, and accomplish goals with minimal supervision • Ability to lead and motivate a team remotely • Ability to provide experience and input into monitoring and site management process initiatives • Strong customer focus and professional interaction with sponsors • Extensive understanding of clinical research principles and processes • Strong understanding of FDA and/or EU Directive regulations, ICH Guidelines, and local regulatory requirements • Experience in the study therapeutic indication/area • Thorough understanding of standard operating procedures • Proficient knowledge of Microsoft Office, eCRF, and IVRS packages • Proficiency with IxRS, CTMS, and EDC systems • Four-year college curriculum or equivalent with a major concentration in biological, physical, or health studies and a minimum of three years as a Senior Clinical Research Associate (or equivalent), OR two-year college curriculum or equivalent education/training and a minimum of five years as a Senior Clinical Research Associate, OR minimum six months functioning as CTM/LCRA (or equivalent), supporting a main CTM and coordinating clinical operations activities • Travel required • Valid current passport required • Driving license required

🏖️ Benefits

• Collaborative and inclusive work environment • Career growth opportunities • Learning and development opportunities • Opportunity to contribute to life-changing clinical research • Remote work arrangement