Dan Nerheim
Clinical Project Manager | Leading Cross-Functional Operations | Expert in Study Delivery, Compliance, and Risk-Based Management.
- Role
- Lead Project Coordinator at HiRO - Harvest Integrated Research Organization
- Location
- Minneapolis, MN, US
- LinkedIn followers
- 500 followers
About Dan Nerheim
Clinical Research Project Manager leading study-level project management within CRO and…
Experience
Lead Project Coordinator
HiRO - Harvest Integrated Research Organization
Jan 2024 — Present
Act as the main point of communication regarding project logistics/management and liaison between clients and vendors for assigned projects.• Support the business development team by providing operational input for proposals, bid defenses, presenting colleague therapeutic experience, and manage listing of sites and investigators. • Contribute to the comprehensive process of researching, assessing, and selecting qualified clinical trial sites and investigators, including conducting feasibility assessments, analyzing patient populations, and evaluating site capabilities and resources.• Oversee the end-to-end operational execution of expanded access programs including management of all aspects of study start-up, IP delivery and management, monitoring, and final TMF delivery. • Track project expenses, review invoice accuracy, forecast expenses, manage contract amendments. • Ensure the creation, review, and timely delivery of essential study documents like protocols, ICFs, CRFs, study manuals/plans/guidelines, and trackers. • Responsible for coordinating and overseeing the preparation, review, and timely submission of all necessary regulatory documents to ethics committees/IRBs. • Track study progress, produce regular progress reports, and present findings to clients and senior management. • Identify areas for operational efficiency within HiRO and participate in developing new SOPs or best practices. • Perform regular visits to investigator sites (or conduct remote monitoring) to verify the conduct of the drug or device trial is in compliance with the currently approved protocol/amendment(s), ICH-GCP, applicable regulatory requirements, and HiRO/sponsor SOPs. • Design and implement a structured training program for Clinical Trial Assistants (CTAs) covering core clinical research principles, regulatory requirements (GCP), essential document collection and management throughout study lifecycle, study-specific procedures, and internal SOPs.
Education
University of Minnesota School of Public Health
Clinical Research Certificate Program
University of Minnesota Duluth
Bachelor's degree
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