Senior Associate - Central Monitor, Risk Based Monitoring

November 5

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Logo of Pfizer

Pfizer

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

•The Sr. Central Monitor is responsible for ensuring the completeness, quality and integrity of clinical trial data in Pfizer's Risk Based Monitoring (RBM) ecosystem •Developing Risk-Based Monitoring system for applicable studies •Ensuring key risk indicators (KRIs) are properly defined and configured to support the study •Processing and reviewing study data for risk signals and action management •Following up through issue resolution •Ensure risk-based monitoring activities comply with regulations, applicable Standard Operating Procedures (SOPs) and processes at all times •Translate between the technical team and study team, providing end-to-end support of clinical trials risk-based approaches

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 to include medical, prescription drug, dental and vision coverage

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