Carol Beirne
Carol Beirne has over 27 years of experience at Abbott Laboratories in a variety of quality leadership roles, most recently as a senior manager in the Corporate Quality Organization. She has worked in both the pharmaceutical and medical device product areas. Beirne designed the management review procedure for the Diagnostics Division and represented the process and data to both internal and external auditors, including ISO and FDA. She has a bachelor of science in engineering that allowed her to be extensively involved in process improvements throughout her career. She led a division Quality Training staff in the Global Pharmaceutical Research and Development organization with employees in both Germany and the US. She has an ASQ Quality Manager/Operations Excellence Certification and has served in multiple roles in CAPA investigations. Beirne earned her International MBA from Keller Graduate College of Management.
Sheri Jacobsen has over 20 years of experience in the pharmaceutical research industry, having held multiple roles across all levels of industry including the areas of site investigation, clinical research organization and biopharmaceutical sponsorship. Currently, Jacobsen is responsible for ensuring that all functions supporting global pharmaceutical development at AbbVie have the training needed to execute clinical programs while ensuring regulatory compliance. She has an MA in clinical psychology with a concentration in neuropsychology from the Illinois School of Professional Psychology and a nursing degree.
Nick McWilliams
Currently teaching:
Responsible Conduct of Research
Drug and Biologics Regulations
Nick McWilliams has been in the pharmaceutical research industry since 2005. He has held roles within data management, clinical operations, and project management. His current position is Senior Clinical Project Manager at IQVIA Biotech, working on oncology studies with emerging biotech and non-profit industry sponsors. He graduated from the MSRC program in 2015 and is excited to bring his experience back to Northwestern to share with students.
Ruby Upadhyaya presently serves as Vice President of Operations Quality & Regulatory Compliance McKesson, a leading healthcare company in medical devices & pharmaceutical supply chain. In her role, Ruby is responsible for driving end-to-end quality at both the distribution facilities as well as sites performing manufacturer services for McKesson's Medical-Surgical division. Ruby has experience in developing commercial regulatory capabilities, launching new products across multiple geographical regions and leading facilities to ISO certifications. In addition to healthcare, Ruby has spent several years in electronic manufacturing, institutional research & consulting organizations. Ruby has BS in electronics & communication Engg from North-Eastern Hill University & MS in an allied field of industrial engineering (majoring in planning & forecasting) from DAVV University. Ruby also has regulatory affairs certificate in medical devices & pharmaceuticals from RAPS, PMP from PMI and has earned multiple ASQ certifications (CBA, CMQ/OE, CQA, CQE, CSSBB) through the course of her professional career.
Lauren has over 15 years of experience in Hematology/Oncology clinical research operations spanning industry and academic healthcare. Her primary responsibilities include planning, organizing, directing, and overseeing daily operations for over 300+ therapeutic clinical trials within a section that accrues approximately 1200+ patients a year to interventional trials. Lauren assists in developing and executing strategic and operational plans (including fully integrated network sites) for clinical research, including new business practices and Standard Operating Procedures (SOPs). Lauren holds an MSc degree in Clinical Research Administration from George Washington University. In addition to her above-mentioned role, Lauren is an appointed Institutional Review Board (IRB) and Clinical Trial Scientific Review (CTRC) committee member at the University of Chicago. Prior to taking her role in the academic setting, Lauren worked at an Oncology CRO, Theradex, where she gained experience in clinical trial monitoring, auditing, and project management. Lauren traveled to several NCI-designated cancer centers to conduct site visit audits. Lauren has a strong passion for teaching and mentoring others about the exciting career opportunities in the field of clinical research.