In this episode of “Moving Medicine Forward” – The Podcast, Jamie Meisenhelder, Chief Administrative Officer (CAO) at CTI, joins us to reflect on her unique journey from law to leadership and how she oversees CTI’s legal, QA, and administrative functions. She shares how her team supports clinical trials, tackles global regulatory challenges, maintains quality standards, and keeps patient trust as the focus. Plus, we explore the future of clinical research and what it takes to stay competitive in an evolving industry.
00:48 Jamie Meisenhelder, CAO of CTI, joins to discuss the roles of QA, legal, and administrative teams.
01:14 Jamie shares her unique path from litigation and finance to joining CTI as a corporate attorney.
01:40 Overview of Jamie's responsibilities: legal, QA, executive admin, and special initiatives.
02:27 How Jamie manages strategic, legal, and QA duties since stepping into the CAO role.
03:15 Her previous experience as Chief of Staff and how it prepared her for broader leadership.
04:07 Strategies for aligning executive leadership and communicating priorities across departments.
05:33 Moving quickly while maintaining quality in contracts and clinical trial agreements.
06:14 Tackling audits, validations, and regulatory demands in global clinical trials.
07:13 CTI’s approach to managing regulations across regions and the role of QA in this evolution.
08:05 Use of SOPs and how consistency is ensured in global projects.
09:27 How a patient-first approach at CTI mitigates legal and reputational risks.
10:06 Jamie reflects on changes in legal and regulatory landscapes during her time at CTI.
11:02 The critical role of confidentiality and how it supports patient trust and sponsor confidence.
12:14 Challenges and opportunities for contract research organizations, focusing on competition, efficiency, and talent retention.