Manager, Clinical Trial Management – Oncology

🔥 5 hours ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

💵 $112k - $222k / year

⏰ Full Time

🟠 Senior

🔴 Lead

🧪 Clinical Research

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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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 the quality and timely delivery of site management services provided by assigned Clinical Research Associates across therapeutic programs and projects • Provide therapeutic and operational expertise throughout the program and project delivery lifecycle • Help ensure appropriate resourcing and effective delivery strategies • Partner with Project Management, Site Management, Study Start Up, therapeutic teams, and Global Quality Assurance to coordinate clinical delivery and address project needs • Develop Clinical Research Associates and Lead Clinical Research Associates through project-specific training, including SOPs, quality improvement and CAPA requirements, and Clinical Monitoring Plans • Monitor clinical quality and project health through site visit report compliance, source data verification, onsite activity, data query status, scope of work, and resource status • Serve as a key contact for the Project Management Franchise Lead • Support proposal defense and client meetings for new and ongoing business as needed • Identify opportunities to strengthen performance and quality, including training needs arising from CAPA information • Manage assigned staff, including the quality of their clinical work and appraisal performance reviews • Collaborate with global teams across multiple time zones

🎯 Requirements

• A four-year college curriculum with a major concentration in biological, physical, health, pharmacy, or another related science, plus eight years of clinical research experience as a Clinical Research Associate; or equivalent education/training plus ten years of Clinical Research Associate experience • At least two additional years of experience managing Clinical Trial Managers • Ability to lead staff and support effective clinical delivery • Broad protocol knowledge and comprehensive understanding of the biopharma industry, drug development lifecycle, and operational clinical trial delivery • Therapeutic knowledge is desired • Strong knowledge of FDA regulations, ICH Guidelines, HIPAA, clinical research principles, and standard operating procedures • Experience navigating EDC systems, including InForm and Medidata • Understanding of clinical data collection and editing • Strong strategic thinking and problem-solving skills • Ability to make decisions, plan effectively, stay organized, and maintain attention to detail • Excellent written, verbal, and interpersonal communication skills • Proficiency in English • Ability to travel up to 30%, including some international travel

🏖️ Benefits

• Competitive benefits package depending on location • Inclusive and equitable workplace • Transparent compensation and pay equity • Equal employment opportunities • Opportunities to learn, grow, and shape the future of clinical research

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