N. Kofi Addo

About N. Kofi Addo

I specialize in clinical risk oversight for multiphase global clinical trials, ensuring compliance with ICH E6(R2/R3) and GCP principles through risk-based quality management (RBQM) and centralized monitoring. I use data-driven insights, including KRIs and QTLs, to proactively identify and mitigate risks, safeguard patient safety, and maintain trial integrity. My experience spans therapeutic areas such as CNS, neurology, hepatic and renal impairment, and rare diseases, where I deliver tailored risk management strategies for high-complexity protocols.

Experience

1. Clinical Quality Control Oversight Risk Manager

   Shionogi Inc. (U.S.)

   Nov 2023 — Present · Florham Park, NJ, US

   Leading risk assessment and mitigation strategies for multiphase global studies across therapeutic areas such as neurology, hepatic and renal impairment, and rare diseases, including development and maintenance of Risk Assessment Categorization Tools (RACT) and integrated quality risk management plans.• Overseeing centralized monitoring data reviews to ensure timely identification of critical findings and facilitating cross-functional SMEs collaboration to validate risk signals and implement corrective actions.• Implementing and optimizing centralized monitoring plans to detect risks to critical data and processes, protocol deviations, and site performance issues using KRIs and QTLs.• Collaborating with Clinical Quality Oversight to align monitoring deliverables, study plans, and training materials with Shionogi SOPs and RBQM principles.• Advising CRO teams and internal stakeholders on QCO-risk expectations, centralized monitoring processes, and risk-based oversight strategies to ensure study success.

Education

• Rutgers University

  Bachelor of Science (B.S.) Public Health, Public Health

  2013 — 2017

• Boston University School of Public Health

  Master of Public Health

  2017 — 2019

Skills

• Data Analysis
• Photography
• Clinical Trials
• Teaching
• Time Management
• Microsoft Powerpoint
• Community Outreach
• Research
• Event Planning
• Microsoft Office
• Sales
• Leadership
• Teamwork
• Science
• Public Speaking
• Microsoft Excel
• Powerpoint
• Statistics
• Writing
• Strategic Communications
• Pcr
• Staff Development
• Student Affairs
• Student Leadership
• Social Media
• Spss
• Needs Assessment
• Customer Service
• Literature Reviews
• Higher Education
• Microsoft Word
• Team Leadership
• Social Networking