Senior Associate - Central Monitor, Risk Based Monitoring

November 6

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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 the completeness, quality and integrity of clinical trial data • Develop Risk-Based Monitoring system for applicable studies • Ensure key risk indicators (KRIs) are properly defined and configured • Process and review study data for risk signals and action management • Follow up through issue resolution • Ensure risk-based monitoring activities comply with regulations, applicable SOPs and processes • Translate between the technical team and study team • Deliver end to end support of clinical trials risk-based approaches • Implement global strategies, initiatives, processes, and standards • Use clinical trial process experience to translate study risks into technical specifications • Review RBQM system output to tell a compelling story of operational and data risk • Plan and execute communication plans & methods • Resolve conflicts, influence and communicate with key stakeholders

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