Risk and Central Monitoring Manager

Worldwide Holdings Corporation

Job Overview

Location

Virtual United States North Carolina

Job Type

Full-time

Full Job Description

📋 Description

• The Risk and Central Monitoring Manager will coordinate cross-functional risk management and central monitoring activities for assigned clinical trials in accordance with ICH GCP guidelines, ensuring quality and consistency across programs, therapeutic areas, and sponsors.
• Day-to-day responsibilities include developing Central Monitoring Plans, conducting risk assessments, identifying Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs), overseeing central monitoring dashboard setup, performing central monitoring activities such as reviewing KRIs and QTLs for outliers or trends, conducting User Acceptance Testing (UAT) of RBQM technology, maintaining the Risk Library, ensuring inspection readiness, managing budget adherence, and mentoring junior team members.
• Worldwide Holdings Corporation (operating as Worldwide Clinical Trials) is a global, midsize CRO with over 3,500 experts dedicated to improving lives through innovative, high-quality clinical trial execution. The company fosters a diverse, inclusive, and collaborative environment where employees are empowered to thrive and contribute meaningfully to advancing medical research.
• In this role, the individual will deepen expertise in Risk-Based Quality Management (RBQM), gain leadership experience in global clinical trial programs, develop mentoring and cross-functional collaboration skills, and contribute to process improvement initiatives that enhance study quality and compliance.

🎯 Requirements

• BSc/RN or equivalent combination of knowledge, skills, and experience
• At least 5 years of experience in clinical research and at least 3 years of experience and knowledge of Risk-Based Monitoring and associated ICH/Regulatory guidance
• Prior experience in Central Monitor/within Central monitoring, and as a Risk Manager is required
• Excellent communication, presentation, and interpersonal skills
• Ability to apply problem-solving and critical thinking techniques to resolve complex issues and apply a risk-based approach to identify and mitigate potential threats to the successful conduct of a clinical trial

🏖️ Benefits

• Opportunity to work with a global team of over 3,500 experts in a mission-driven organization focused on improving lives through clinical innovation
• Access to a diverse, inclusive, and supportive workplace culture that encourages collaboration, creativity, and professional growth
• Mentorship opportunities to guide and develop new/junior team members while building leadership experience
• Exposure to cross-functional programs, therapeutic areas, and sponsor interactions, enhancing strategic and operational expertise in clinical trials
• Commitment to employee development through involvement in department strategy, process initiatives, and continuous learning in RBQM and central monitoring technologies

Skills & Technologies

GCP

Onsite

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Worldwide Holdings Corporation

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About Worldwide Holdings Corporation

Worldwide Holdings Corporation is a diversified global enterprise engaged in the development, manufacturing, and marketing of a wide range of products and services. The company operates across various sectors, including technology, consumer goods, and industrial solutions, with a strong focus on innovation and sustainability. Worldwide Holdings Corporation is committed to delivering high-quality products and exceptional customer service, aiming to foster long-term relationships with its clients and stakeholders. The company's strategic vision involves expanding its global reach, investing in research and development, and adapting to evolving market demands to maintain a competitive edge in the international marketplace. Their mission is to create value through responsible business practices and a dedication to excellence.

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