Principal Clinical Data Manager

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $99k - $196k / year

⏰ Full Time

🔴 Lead

🧪 Clinical Research

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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 end-to-end clinical data management activities across multiple complex global projects and programs • Ensure data management deliverables, timelines, budgets, and resources are effectively planned and managed • Oversee development and review of Data Management Plans, database specifications, edit checks, and data transfer agreements • Direct user acceptance testing, data cleaning strategies, reconciliation activities, and database lock readiness • Monitor study progress through metrics and identify, communicate, and mitigate project risks and scope changes • Serve as the primary data management representative in internal and sponsor-facing meetings • Act as a subject matter expert for data management processes, driving process optimization, training, quality improvement, and CAPA activities • Mentor and support data management colleagues and contribute to departmental initiatives and operational excellence programs • Support business development activities, sponsor audits, inspections, and stakeholder engagements

🎯 Requirements

• Bachelor's degree or higher in biomedical sciences, life sciences, computer science, or a related field, or equivalent relevant experience • Minimum 7 years of clinical data management experience or related experience within the pharmaceutical, biotechnology, or medical device industries • Expert knowledge of clinical data management best practices, technologies, and processes supporting clinical trials • Advanced understanding of clinical trial documentation and processes, including protocols, CRFs, statistical analysis plans, and study reports • Proven ability to independently lead and oversee complex global clinical data management projects • Strong analytical, problem-solving, and decision-making skills with exceptional attention to detail • Excellent communication and interpersonal skills with the ability to collaborate effectively across internal and external stakeholder groups • Proficiency in English

🏖️ Benefits

• Competitive benefits package depending on location • Inclusive and equitable workplace • Equal employment opportunities • Transparent compensation and pay equity

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