Amy Hessenthaler
Senior Global Project Manager at mdgroup- Claim this Profile
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Bio
Experience
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mdgroup
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United Kingdom
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Pharmaceutical Manufacturing
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100 - 200 Employee
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Senior Global Project Manager
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Jul 2022 - Present
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Global Project Manager
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Apr 2021 - Jul 2022
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Advocate Aurora Health
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United States
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Hospitals and Health Care
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700 & Above Employee
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Research Business Services Specialist Senior (Advocate Aurora Research Institute)
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Oct 2018 - Apr 2021
- Core team member for two separate implementations of a new Clinical Trial Management System (CTMS), including planning discussions, transferring of protocol calendars, billing designations, budgets, and training of staff- Coordinated a quality assurance process for identifying and correcting historic research trial inconsistencies to ensure accurate billing and invoicing prior to release of studies in the new CTMS - Assisted with the merger of separate Aurora and Advocate budgets and contracts processes into one cohesive process, including the combination of fee schedules, time and effort budgeting, and the study start-up workflow- Collaborated with the CTMS vendor to improve the financial platform of the system to meet the evolving needs of the research institute and other external healthcare systems- Mentored team members on job responsibilities, clinical research processes, and best practices - Developed standard operating procedures, guidance documents, and additional training resources to be used by the Research Business Services department and other departments across the organization- Led and coordinated a working group that spanned across multiple departments to create better processes for budgeting and revenue collection
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Clinical Trial Business Services Specialist (Aurora Research Institute)
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Aug 2016 - Oct 2018
- Reviewed and negotiated original and amended contracts and budgets between Aurora Research Institute and clinical trial sponsors - Completed comprehensive reviews of protocols to develop internal clinical trial budgets that are inclusive of all procedural and staff costs- Partnered with clinical research coordinators and service line managers to ensure all study-related items are included and priced appropriately from the charge master- Collaborated with research billing analysts to ensure budgets and Medicare Coverage Analyses include appropriate CPT codes and billing designations- Led meetings to ensure all study team members understand contract and budget requirements prior to the study opening to enrollment at Aurora- Reviewed all study documents, including informed consent form, contract and budget, to certify consistency across documents - Tracked all study-related timelines and provide updates to leadership, study staff, and investigators on study progress
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Wheaton Franciscan Healthcare
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United States
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Hospitals and Health Care
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700 & Above Employee
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Clinical Research Coordinator (Neonatal, Prenatal, End Stage Renal Disease, and Cardiology)
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May 2014 - Aug 2016
- Initiated and led study start-up processes, including feasibility meetings, Institutional Review Board meetings, site initiation visits with study sponsors, and training with hospital staff - Worked with study sponsors to implement protocol changes to study and report study-related adverse events in the appropriate time frame - Mentored new associates on department responsibilities, Good Clinical Practice regulations and clinical research processes - Served as a representative for the department on committees implementing the EPIC Electronic Health Record System - Screened, consented, and enrolled patients in studies for various populations (Cardiology, Prenatal, Neonatal, and End Stage Renal Disease) - Project team member for implementation and maintenance of Clinical Trial Management System - Communicated with patients and families from diverse socioeconomic backgrounds about study involvement - Traveled to various clinic locations and hospitals to complete subject follow-up visits
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Medical College of Wisconsin
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Higher Education
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700 & Above Employee
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Clinical Research Coordinator (Emergency Medicine)
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Aug 2012 - May 2014
- Screened, enrolled, and consented patients for seven different studies - Partnered with other departments (trauma, neurology, and neurosurgery) and institutions - Tracked each participant’s timeline and study-related deadlines - Scheduled and conducted follow-up with participants - Communicated with patients and families about study involvement - Created manual of operations for data collection and management - Updated web-based tracking logs and work with program monitors to troubleshoot data issues - Directly monitored patient care and aided treating teams in ensuring protocol compliance - Documented and maintained detailed patient care charts throughout study involvement - Traveled into the community to provide feedback to paramedics and complete follow-up with patients - NIH and CITI certified
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Waisman Center
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Madison, Wisconsin Area
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Research Assistant (Center for Investigating Healthy Minds)
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2010 - 2012
- Ran experimental tasks and monitored data collection - Recruited and screened participants for four cohorts during the study - Scheduled participants’ attendance for sessions - Managed study files and materials for participants - Coordinated travel accommodations for subjects from around the country - Completed data entry and cross-checked spreadsheets to assure data integrity - Trained fellow research assistants in preparing for and conducting experimental sessions - Ran experimental tasks and monitored data collection - Recruited and screened participants for four cohorts during the study - Scheduled participants’ attendance for sessions - Managed study files and materials for participants - Coordinated travel accommodations for subjects from around the country - Completed data entry and cross-checked spreadsheets to assure data integrity - Trained fellow research assistants in preparing for and conducting experimental sessions
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Education
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University of Wisconsin-Madison
Bachelor of Arts (BA), Communication Sciences and Disorders