Michelle Marsicek
Director of Customer Success at ConcertAI- Claim this Profile
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Bio
Credentials
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Artificial Intelligence in Pharma and Biotech
MIT Sloan Executive EducationJan, 2022- Nov, 2024 -
Medidata Rave Study Design and Build Essentials (SDBE) – Data Managers
Medidata SolutionsJul, 2019- Nov, 2024 -
Medidata Rave Study Design and Build Essentials (SDBE) – Data Validations
Medidata SolutionsJul, 2019- Nov, 2024 -
Certified Clinical Research Professional (CCRP)
Society of Clinical Research Associates (SOCRA)Mar, 2021- Nov, 2024 -
Certified Clinical Research Coordinator (CCRC)
Society of Clinical Research Associates (SOCRA)Mar, 2017- Nov, 2024
Experience
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ConcertAI
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United States
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Biotechnology Research
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700 & Above Employee
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Director of Customer Success
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Aug 2022 - Present
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Alliance Manager, Customer Success
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Jul 2021 - Present
A part of the Customer Success team, leading high-profile initiatives and driving innovation by collaborating with cross-functional partners and team members to deliver value to our clients. Define, implement and manage the roadmap and deliveries for ConcertAI’s portfolio of products, including RWD data products, platforms, and services to our client partners. Propel innovative and cutting-edge solutions in AI/ML, platforms, and real world data to improve oncology therapeutics and impact patient lives. Show less
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AbbVie
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United States
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Pharmaceutical Manufacturing
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700 & Above Employee
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Clinical Systems Designer
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Mar 2019 - Jul 2021
- Perform design activities related to core trial-specific systems through a thorough understanding of the clinical trial protocol for global trials. - Ensure consistent user interfaces and system standards across clinical trials providing an optimal end-user experience through well-defined system designs. - Support organizational interests related to critical governance, quality and compliance, and regulatory agency inspections. - Engage with other members of the cross-functional and internal study teams in order to execute assigned activities. - Ensure compliance with established data standards to be used in the design and development of clinical trial systems, benchmarked against industry standards. Accountable for seamless execution of assigned deliverables following quality standards (ICH/GCP, Global Regulations, and Clients policies and procedures) and defined department level processes. Accountable for the on-time design and delivery and changes of clinical systems (e.g. EDC, IRT, and ePRO) during the lifecycle of the clinical trial based on the requirements of the protocol. - Utilize operational data and analytical tools to optimize execution of the assigned clinical trials and to identify key areas of risk that may require escalation. - Designed trials within CDISC and CDASH conformance. Show less
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The US Oncology Network
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Hospitals and Health Care
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700 & Above Employee
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Clinical Research Coordinator
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Sep 2014 - Mar 2019
- Enlisted, maintained and assured protocol compliance for all patients within trials for various solid tumor types including breast, cervical, gastroesophageal, gastric, head & neck, hepatocellular, lung, ovarian, pancreatic, prostate, renal, urothelial and uterine within Phase I - IV, registry and expanded access trials. - Coordinated trials for hematological disorders such as PNH & anemias and hematological malignancies including leukemias, lymphomas and myeloma. - Oversaw trials in a broad range of settings including interventional, diagnostic and device trials for both pharmaceutical sponsored and cooperative group led trials (RTOG, NRG, ECOG-ACRIN). - Assured protocol compliance for all patients enrolled in the trial, participated in the informed consent process, performed ongoing assessments and documentation. Oversaw blood and tissue sample collection and processing within protocol guidelines. - Trained staff on protocol requirements and promoted available trials within the community. - Ensured quality site practices by following US Oncology SOP's and compliance standards, principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations through OSHA, CDC and HIPPA. Show less
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Non-Profit and Grants Consultant
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Jan 2007 - Sep 2014
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Ballard Healthcare
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United States
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Food and Beverage Services
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1 - 100 Employee
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Clinical Researcher and Grant Writer
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Jan 2008 - May 2010
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Education
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Logan University
Master of Science - MSHI, Health Informatics -
Padua Franciscan High School
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Spertus Institute for Jewish Learning and Leadership
Grantwriting Certificate, Non Profit Management -
US Government Grants
Certification in Grant Writing, Grant Writing -
University of Illinois at Chicago
Bachelor of Science - BS, Biological Sciences