Senior Associate, Central Monitor - Risk Based Monitoring

November 7

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Pfizer

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To apply science and our global resources to improve health and well-being at every stage of life. We strive to provide access to safe • effective and affordable medicines and health care services to the people who need them.

10,000+

💰 Post-IPO Debt on 2023-05

Description

•Ensure completeness, quality and integrity of clinical trial data in Pfizer's Risk Based Monitoring (RBM) ecosystem •Develop Risk-Based Monitoring system for applicable studies •Ensure key risk indicators (KRIs) are properly defined and configured to support the study •Process and review study data for risk signals and action management •Follow up through issue resolution •Deliver end to end support of clinical trials risk-based approaches •Implement global strategies, initiatives, processes, and standards •Translate study risks into technical specifications that support monitoring •Review RBQM system output to communicate operational and data risk for study team action •Plan and execute communication plans & methods for customer satisfaction •Resolve conflicts and communicate with key stakeholders and customers

Requirements

•Bachelor’s degree or above or equivalent experience in a scientific or business related discipline required •3 - 5 years working experience in the clinical development fields •Working knowledge of clinical development process, understanding concepts of Phase I-IV and principles of study design •Previous experience within clinical trials, understanding key processes and principles associated with clinical database set-up, external data flow, and site monitoring activities •Knowledge of clinical trial databases and all clinical trial data sources •Knowledge of Windows Environment and its applications (Word, Excel, PowerPoint, Project, etc.) •Technical expertise and business experience in supporting clinical trials such as obtained through database development, data management, site monitoring, etc. •Thorough understanding of the processes associated with clinical study management, data management, and regulatory operations •Project management skills and technical capabilities as well as effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization •Self-motivated with an ability to organize tasks, time and priorities; ability to multi-task •Ability to communicate effectively and appropriately with internal & external stakeholders, locally and globally •Strong understanding of the state-of-the-art technologies to evaluate and leverage them into improved business processes for worldwide deployment and adoption

Benefits

•401(k) plan with Pfizer Matching Contributions •Additional Pfizer Retirement Savings Contribution •Paid vacation •Holiday and personal days •Paid caregiver/parental and medical leave •Health benefits including medical, prescription drug, dental and vision coverage