Clinical Trial Manager – Oncology

🔥 3 minutes ago

🌐 Mexico, Brazil, +3 more countries – Remote

🇲🇽 Mexico – Remote 🇧🇷 Brazil – Remote 🇨🇱 Chile – Remote 🇨🇴 Colombia – Remote 🇦🇷 Argentina – 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 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 the protocol, study plan, and Worldwide SOPs • Ensure quality and timeliness of clinical deliverables for assigned programs or regions • Collaborate with Project Management to establish site-management targets and monitoring strategy • Provide leadership and direction to clinical site-management team members from study start through closure • Serve as primary Site Management contact for clinical monitoring and site activities • Manage monitoring deliverables, study budgets, out-of-scope activities, and quality-management documents such as Clinical Monitoring Plans • Oversee compliance with the Clinical Monitoring Plan, site visits, trip reports, follow-up letters, 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, review data metrics, and address issues with action plans • Track site-management deliverables, trends, analytics, financial performance, resources, and time recognition • Oversee Trial Master 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 • Escalate monitoring and site issues, propose solutions, and mitigate risks • Represent Site Management as primary project contact when needed • Conduct co-visits to ensure site, CRA, and study-procedure quality

🎯 Requirements

• Excellent interpersonal, oral and written communication skills in English; Portuguese preferred • Excellent planning, organizational, presentation, and time-management skills • Ability to manage multiple tasks, negotiate diplomatically, prioritize, plan proactively, and work with minimal supervision • Ability to lead and motivate a team remotely • Experience and input into monitoring and site management process initiatives • Strong customer focus and professional sponsor interaction • 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 at least three years as a Senior Clinical Research Associate (or equivalent), OR two-year college curriculum or equivalent education/training and at least five years as a Senior Clinical Research Associate, or at least six months functioning as CTM/LCRA (or equivalent) while supporting the main CTM and coordinating clinical operations activities • Valid current passport required • Driving license required • Travel required

🏖️ Benefits

• Equal employment opportunity • Diverse and inclusive work environment • Supportive, team-oriented atmosphere • Hands-on, accessible leadership • Professional growth and opportunity to succeed