Program Clinical Data Manager

🔥 12 hours ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

💵 $99k - $196k / year

⏰ Full Time

🟠 Senior

🔴 Lead

🧪 Clinical Research

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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 data management activities independently across multiple complex global projects and programs from study start-up through conduct and close-out • Develop and oversee Data Management Plans, database specifications, edit check specifications, CCGs, and Data Transfer Agreements • Drive UAT, data cleaning, external vendor reconciliation, progress metrics, and timely database lock activities • Manage data management resources, timelines, scope, budgets, and risks; escalate concerns and keep leadership informed • Represent Data Management in internal and external study meetings with sponsors and cross-functional teams • Serve as a subject matter expert, providing guidance and training while driving quality issue resolution, root cause analysis, CAPAs, and guidance-document updates • Mentor Data Management colleagues and co-lead departmental process, quality, and efficiency initiatives • Support sponsor proposals and presentations and contribute expertise during sponsor audits, regulatory inspections, and third-party meetings

🎯 Requirements

• Bachelor’s degree or higher in biomedical sciences, life sciences, computer science, or a related discipline, or equivalent relevant experience • Minimum of 7 years of experience in clinical data management or a related role within the pharmaceutical, biotechnology, or medical device industries • Expert knowledge of clinical data management best practices and technologies as applied to clinical trials • Advanced understanding of the clinical trial process and key study documents, including protocols, statistical analysis plans, CRFs, and study reports • Ability to independently oversee complex projects, solve problems, analyze issues, and maintain strong attention to detail • Excellent written, verbal, interpersonal, and cross-functional communication skills • Proficiency in English

🏖️ Benefits

• Competitive benefits package depending on location • Inclusive and equitable workplace • Equal employment opportunities • Opportunities to learn and grow • Mentoring and professional development through training

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