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Pam is a registered pharmacist and has over 15 years of experience in the pharmaceutical industry. Specializing in the clinical development process, Pam works with pharmaceutical and medical device clients, as well as clinical trial sites in the areas of clinical trial operations, global clinical development, investigator site training and monitoring, and clinical trial compliance.
Professional Experience
Prior to joining Huron, Pam was an associate director with Navigant Consulting. At Navigant, she assisted in the creation of the Clinical Trial Operations and Compliance segment of the Life Sciences practice.
Prior to her role at Navigant, Pam held various roles in Clinical Development and Clinical Operations for The Upjohn Company, Pharmacia, and Pfizer, Inc. Her roles within these international pharmaceutical manufacturers included global development of CNS drug candidates through NDA filing, management of the U.S. Investigator Contracts and Grants function, global training and development, and participation in a clinical development process redesign.
Pam’s experience includes helping clients with the following:
Optimization of clinical development process from protocol development through regulatory filing;
Monitoring and auditing clinical trial sites;
Clinical contract development, grant payments, and associated compliance; and,
Creation of procedures, training plans, and training program implementation.
Representative examples of Pam’s experience in the healthcare industry include:
Development and implementation of a process for executing clinical trial agreements and associated study grant payments for Phase I through IV clinical programs.
Assessment of compliance with Investigator Initiated Trial contract terms and creation of a system for tracking IITs.
Compliance assessments for academic medical centers conducting clinical research including IRB review, clinical trial billing, and patient inclusion.
Development of global codes of conduct.
Assessment of medical sales liaisons (MSLs) processes.
On-site study monitoring and auditing of ongoing clinical trials at investigator sites.
Protocol design for Phase II-III global registration clinical trials.
Creation of a capacity planning system to facilitate study placement, workload distribution, and resource forecasting for clinical trials in non-U.S. regions.
Assessment of staff training needs and development of related training programs, as well as defining a strategy for external customer training programs.
Development and implementation of an extensive global training program for clinical investigators and site staff to improve site staff understanding of clinical trial conduct and associated compliance.
Assisting pharmaceutical clients with development of product labeling consistent with FDA guidance and practitioner usage.
Process development for clinical trial sites.
Education & Certifications
Master of Business Administration, University of Notre Dame, Notre Dame, IN
Bachelor of Science, Pharmacy, Drake University, Des Moines, IA
Registered Pharmacist, Michigan
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