Study Manager II (Sr. Manager) at Pfizer

• As a Study Manager II, your advanced knowledge of the principles and concepts in the discipline and comprehensive knowledge of other disciplines will enable you to lead complex projects across the division. Your ability to develop and manage plans will facilitate in achieving objectives, interpreting internal and external business challenges and recommending best practices for improvements. While managing complex project environments, you will be able to anticipate and troubleshoot roadblocks and influence teams to achieve targets for the division.
• It is your problem solving ability and patience that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

• Develop ideas, lead/co-lead complex projects across business units and develop plans to achieve objectives.
• Approve the Study Startup, Study Monitoring and protocol recruitment plans.
• Resolve escalated issues identified by the site activation subteam in partnership with the Study Manager.
• Work proactively with Clinical Research Organizations (CRO) and data management functions to ensure alignment on data flow and timely delivery.
• Manage Operational Study Management for one or more studies of limited complexity or a unique part of a larger study.
• Forecast and manage the Clinical Trial Budget for the program.
• Provide country and regional level input to country outreach surveys.
• Create awareness by working as a cross functional Team Leader to deliver site intelligence initiatives with a variety of stakeholders, both internal and external.
• Approve and oversee drug supply management, manage flow of drug supply to the sites.
• Participate in global initiatives to improve operational efficiencies.
• Evaluate study progress reports and results for overall compliance and recommends corrective action or study termination for non-performance.
• Maintain regular communications with investigator sites to gather status updates, informal and formal performance metrics, and study-level feedback.

Qualifications

Must-Have

• Bachelor's Degree
• Strong relevant experience
• Applicable pharmaceutical industry experience
• Working knowledge of Good Clinical Practices, monitoring, clinical and regulatory operations
• Demonstrated project management / leadership experience
• Experience with CRO oversight
• Ability to evaluate, interpret and present complex issues and data to support risk
• Excellent communication skills, both written and verbal; must be fluent in English
• Effective decision maker, analytical and solution-oriented
• Proficiency in Microsoft Office Suite

Nice-to-Have

• Master's degree.
• Broad based experience in clinical research
• Strong knowledge of Inflammation and Immunology, subject matter expertise and international experience