Clinical Data Manager

🔥 5 minutes 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, database lock, and close-out • Plan resources, timelines, budgets, scope, and risks, and escalate concerns appropriately • Develop and oversee Data Management Plans, database and edit check specifications, completion guidelines, data transfer agreements, and vendor reconciliation specifications • Drive user acceptance testing, data cleaning, reconciliation, metrics reporting, and database lock activities • Partner with sponsors and internal cross-functional teams and represent Data Management in study meetings • Serve as a subject matter expert, providing guidance and training and maintaining process documentation • Lead responses to process-related quality issues, including root cause analysis and corrective and preventive actions • Mentor Data Management colleagues and contribute to departmental process, quality, and efficiency initiatives • Support business development proposals and sponsor presentations • Participate in sponsor audits, regulatory authority inspections, and other third-party meetings as needed

🎯 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 clinical data management or related experience 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 documents, including protocols, statistical analysis plans, CRFs, and study reports • Strong independent leadership, analytical, and problem-solving skills • Excellent attention to detail • Excellent communication and interpersonal skills • Proficiency in English, with strong written and verbal communication skills

🏖️ Benefits

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

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