Jessica Guider
Senior Clinical Trial Manager @辉瑞
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WORK HISTORY
Senior Clinical Trial Manager @辉瑞
Lead and manage global clinical trials across multiple therapeutic areas, including oncology, cardiovascular, respiratory, and rare diseases. Oversee the full lifecycle of clinical trials from protocol development to clinical study report (CSR) submission, ensuring compliance with GCP/ICH guidelines and regulatory requirements. Coordinate cross-functional teams, including internal stakeholders, vendors, and external partners, ensuring smooth and efficient study conduct. Manage study timelines, milestones, and deliverables; proactively identify and resolve issues to mitigate risks and maintain study progression. Lead the development of study plans, review monitoring visit reports, and perform on-site visits as needed for study oversight. Implement appropriate systems and processes to ensure the quality and integrity of clinical trial data.
EDUCATION
Benedictine University
Master of Public Health (MPH), Epidemiology and Statistics
Benedictine University
Master of Business Administration (MBA), Health Economics
Loyola University Chicago
Bachelor of Science (BS), Medical Microbiology and Bacteriology
SKILLS
ABOUT JESSICA GUIDER
As a Senior Clinical Trial Manager with over 18 years of experience, I specialize in managing large-scaleglobal clinical trials across a wide variety of therapeutic areas, including oncology, cardiovascular,dermatology, infectious diseases, and rare diseases. I am passionate about advancing healthcare throughwell-managed clinical research, and my expertise spans from Phase I-IV trials to medical device studies,ensuring that regulatory compliance, data integrity, and quality standards are met at every step.I have a strong background in leading cross-functional teams, managing complex timelines, andcoordinating with diverse stakeholders to drive clinical trials to successful completion. From studyinitiation through database lock, I’ve delivered numerous projects on time and within budget. Myexperience extends across North America, Europe, Asia, and Australia, and I’ve successfully managedclinical trials in multi-center settings.I am a certified Project Management Professional (PMP) and Six Sigma Green Belt, and I am adept at using project management tools such as MS Project and Medidata RAVE to keep studies on track. With a deep understanding of clinical data management systems, I provide oversight on data quality and ensure that findings are accurate and actionable. I am also experienced in medical device trials, includinginvestigational devices for cardiovascular indications.Throughout my career, I’ve been able to combine my technical expertise with a focus on leadership,communication, and collaboration to drive excellence in clinical research. I am excited about theopportunity to continue contributing to the growth of the clinical research industry and the development of innovative treatments that can make a real difference in patients\' lives.
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