Pfizer Study Manager II (Sr. Manager) in Remote, United States
Why Patients Need You
Pfizer Worldwide Medical and Safety colleagues play a key role in connecting evidenced based, medical decision support with colleagues and stakeholders to enable better health and treatment outcomes. Whether you are creating framework necessary to ensure our evidence is scientifically sound, providing unbiased, medically necessary expertise or investigating how to close gaps in data, our mission is simple. Empower healthcare decisions regarding the safe and appropriate use of medicines for patients.
What You Will Achieve
You will be part of Pfizer's medical team and manage the clinical studies. Your project management skills will be leveraged for planning, directing, creating and communicating timelines. You will ensure that the clinical studies are within time, budget and scope.
As a Senior Manager, 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.
7+ years' 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
Broad based experience in clinical research
Subject matter expertise and international experience
This role can be remote based.
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.
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EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.