Michele Marsh Shardinski
About Michele Marsh Shardinski
Michele Marsh Shardinski is an Associate Director at Bristol-Myers Squibb and Merck, with extensive experience in clinical operations and project management across various therapeutic areas.
Professional Titles and Roles
Michele Marsh Shardinski currently holds dual roles as the Associate Director, Operations Portfolio Lead, Immunology, Fibrosis, and CV at Bristol-Myers Squibb in New Jersey, and Associate Director, Oncology Early Development at Merck in Kenilworth, New Jersey. These roles highlight extensive responsibilities in overseeing operations portfolios and early-stage oncology developments.
Previous Industry Experience
Michele Marsh Shardinski has amassed significant experience in various roles. At Execupharm, she worked for three years as the Clinical Operations Lead in Oncology, consulting for Merck. Prior to that, she held a role as Global Clinical Project Manager at PRA Health Sciences, consulting for Amgen for two years. Additionally, she served as a Program Manager for the Abilify Portfolio at Pharmica Consulting Inc, and as a Clinical Project Manager in Oncology at Bioclinica. Earlier in her career, she was a Site Manager at Fef Chemicals A/s for seven years in Denmark.
Educational Background in Business Administration
Michele Marsh Shardinski pursued a comprehensive education in Business Administration. She earned an Associate degree from Axia College and then furthered her studies at the University of Phoenix, where she obtained both a Bachelor's degree and a Master of Business Administration (MBA). Her high school education was completed at Piscataway Township High School.
Clinical Trial Management Expertise
Michele Marsh Shardinski has a proven track record in managing clinical trials across various therapeutic areas, such as immunology, fibrosis, and cardiovascular diseases. She is adept at designing study tools and manuals, including informed consent forms (ICF) and monitoring plans. Additionally, she has extensive experience in managing study budgets, timelines, site recruitment, and retention for clinical studies. Her capability in selecting and managing multiple project vendors further underscores her expertise in clinical trial management.
Project and Team Leadership
Michele Marsh Shardinski excels in leading and managing multiple project teams and studies concurrently. Her roles have required her to effectively balance various projects while ensuring quality and compliance. This experience demonstrates her ability to oversee complex operations and deliver successful outcomes in fast-paced environments.