Kristen Carpenter, is a Senior Clinical Operations Manager Lead at Merck. In this role, Kristen is responsible for oversight of Merck USA country and site level informed consent and IRB related matters.  In addition to managing direct reports, In this oversight role, Kristen was instrumental in implementing a USA Country ICF Mailbox for site specific substantive change language escalations.  She manages a team of informed consent subject matter experts who address informed consent escalations, conduct training, and field general ICF questions from internal and external stakeholders.  In addition to Kristen’s management of the Country ICF Mailbox, she implemented an Informed Consent Language Library of standardized ICF language to build efficiencies and reduce site specific informed consent review times.

Kristen has a bachelors degree from Franklin Pierce College in Rindge, NH and has been working in clinical research since 2003.  During Kristen’s time in clinical research, she has been focused on study start-up operations specializing in, informed consent authoring, review, and negotiation