Clinical Scientist

🔥 16 hours ago

🌐 United States, Canada, +2 more countries – Remote

🇺🇸 United States – Remote 🇨🇦 Canada – Remote 🇲🇽 Mexico – Remote 🇦🇷 Argentina – Remote

🌲 North Carolina – Remote

🌲 North Carolina – Remote

💵 $79k - $157k / 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

• Develop clinical data review plans for assigned studies • Collaborate with cross-functional study team members to ensure protocol-defined variables are collected and reported accurately • Conduct ongoing review and analysis of clinical data, including efficacy and safety-related data components, using listings, tables, figures, graphs, and EDC as needed • Track and analyze potential safety events in collaboration with Pharmacovigilance and Medical Monitoring • Contribute to discussions on potential study or strategy modifications based on clinical data review • Create data summary slides for Safety Review Committee Meetings and Data Review Meetings with support from Director • Present key data trends and findings to the Medical Monitor, Study Team, and Client • Query EDC data as appropriate during clinical review, with timely follow-up and identification of potential protocol deviations • Partner with vendors and study team members to ensure accurate endpoint reporting • Serve as a point of contact for site staff and monitors for protocol and clinical inquiries • Collaborate with Data Management on CRF design, CRF instructions, and data quality plans • Review data-driven sections of regulatory and clinical reporting documents, including CSRs, INDs, NDAs/BLAs, annual reports, and IBs • Provide scientific writing support, including patient narratives, abstracts, posters, and presentations • Mentor and train junior staff • Utilize visual analytics tools to interpret and communicate data insights

🎯 Requirements

• Strong knowledge of clinical development processes and study design principles • Deep understanding of product profiles and safety concepts • Skilled in clinical data analysis, interpretation, and assessing clinical relevance in human clinical trials within the relevant therapeutic area • Proficient with electronic data capture systems and data visualization tools • Solid understanding of GCP, ICH guidelines, and regulatory requirements • Excellent written, oral communication, and presentation skills • Strong organizational, analytical, and problem-solving abilities • Ability to manage multiple priorities and adapt to changing demands • Strong interpersonal skills and ability to collaborate across teams and levels • Demonstrated ability to work independently and within teams • Good judgment and decision-making skills • Willingness to travel as needed • Advanced clinical or scientific degree preferred (e.g., PharmD, PhD, MSN, MPH) with 8+ years of industry-related experience in Oncology • OR Bachelor's degree with 12+ years of relevant industry/research experience in the relevant therapeutic area, including data review and interpretation • Proficiency in Microsoft Office Suite • Experience with EDC systems and data visualization platforms

🏖️ Benefits

• Competitive benefits package depending on location • Transparent compensation and pay equity