Responsible for Quality Assurance at Alimentiv since 2005, Karen has built the QA department into an eight-member team that hosts agency inspections, conducts internal audits, assesses vendors and oversees QA for the organization.
Karen spent 10 years at Eli Lilly in a variety of roles including Data Management, Clinical Monitor, Clinical Project Manager and Training Leader. She has been a member of the SQA since 2006 and was RQAP-GCP certified in 2009.
Successfully hosted the FDA in 2017 with no 483 or verbal observations.
“Kindness, patience and empathy are the most powerful tools in my tool chest.”
A patient reported outcome measure, or PRO, may be defined as “any report of the status of a patient’s health condition that comes directly from the patient, without interpretation of the patient’s response by a clinician or anyone else.” These measures are widely used to study chronic diseases and are considered by regulatory agencies such […]
International Women’s Day And Our Alimentiv Leaders
International Women’s Day 2021 is on Monday, March 8th. Alimentiv is proud to celebrate this, honour the achievements of women across the globe, and continues to foster a culture where all employees and prospective candidates receive equal opportunities. Lisa Harrison, Chief Operating and Privacy Officer for Alimentiv took some time to discuss her growth and […]