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Today, we’re diving into the world of clinical operations with the incredible Kristen Perkins. With over 16 years of experience and the founder of the Clinical Trial Manager, Kristen brings a wealth of knowledge and passion to our discussion. Get ready for an engaging and enlightening conversation!

Kristen is a clinical operations leader located in Greater Boston with 16+ years of Phase I-IV global leadership and clinical trial management experience. She is passionate about patient-focused drug development and supporting people and teams with achieving audacious goals.

Kristen is also the Founder of The Clinical Trial Manager, a platform designed for current and aspiring Clinical Trial Managers in the pharmaceutical and biotech industry. Through free content, online courses, group coaching, and a mastermind program, Kristen supports ambitious clinical operations professionals to step into their full leadership potential.

Highlights of the Episode:

• Kristen’s journey from a research assistant at top medical institutions to a senior director of clinical operations.
• How a research course in college opened her eyes to the clinical research industry.
• The personal impact of her grandmother’s battle with cancer on her career path.
• The importance of patient-focused drug development and holistic healthcare in clinical trials.
• The role of clinical operations as the “Swiss army knife” of clinical trials, requiring diverse skills and relationship building.

Key Takeaways:

• The Power of Networking: Kristen emphasizes the importance of building strong relationships and networks in the clinical research industry.
• Advocacy and Self-Worth: Learn how advocating for yourself, knowing your worth, and understanding fair market value can significantly impact your career and salary.
• Holistic Approach to Healthcare: Kristen’s insights on integrating holistic healthcare practices with traditional clinical research to improve patient outcomes.
• Managing Clinical Trials: The critical role of clinical trial managers in ensuring the success of trials by overseeing internal and external teams, managing vendors, and maintaining high-quality standards.

Episode Highlights:

• [0:01] Suzanne’s warm welcome and introduction of Kristen Perkins.
• [0:30] Kristen’s career journey and her shift from psychology to clinical research.
• [3:00] The personal story behind Kristen’s passion for oncology and patient-focused drug development.
• [9:00] Transitioning from site work to CROs and the challenges of working with paper TMFs.
• [12:00] The critical role of clinical trial managers and the importance of project and people management skills.
• [20:00] Kristen’s advocacy for fair compensation and how to navigate salary negotiations.
• [30:00] The launch of the Clinical Trial Manager and how it supports aspiring clinical trial managers.
• [40:00] Closing thoughts and how to connect with Kristen.

📞 Connect with Kristen:

• Website: www.theclinicaltrialmanager.com
• LinkedIn: linkedin.com/company/theclinicaltrialmanage

📞 Connect with Suzanne:

• Website: https://www.iceconsultingllc.com/home
• LinkedIn: https://www.linkedin.com/in/turnersuzannem/

💌 Feedback and Questions:

• Email Suzanne at podcast@iceconsultingllc.com

🎙️ Tune in and get to know the passionate professional behind Heart of the Trial!

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Today, we dive into the nitty-gritty world of clinical trial compliance with our fabulous guest, Teresa Davis, who brings over 15 years of experience to the table. If you’ve ever wondered about the behind-the-scenes magic that keeps clinical trials running smoothly, this episode is for you!

In this episode, Teresa shares her journey from an English and art background to becoming an Associate Director of Clinical Operations, specializing in clinical compliance. Inspired by her sister and motivated by her niece’s life-saving clinical trial, Teresa's path into the industry is both heartwarming and inspiring.

Teresa’s passions within the industry are Site Monitoring, Risk-based Quality Management (RBQM), Clinical Compliance, and Vendor Governance. She is currently an Associate Director (contractor) of Clinical Operations within a ClinOps Compliance Team.

She is a wife and mother to two children: a son, and a daughter. She spends her time outside of work shuttling kiddos to taekwondo, t-ball, and gymnastics events. Her husband is a full-time football coach.

Highlights of the Episode:

• Teresa’s introduction to clinical research through her sister and the Healthcare Business Women's Association.
• The life-changing impact of her niece’s participation in a clinical trial for pulmonary arterial hypertension.
• Teresa’s deep dive into risk-based monitoring (RBM) and risk-based quality management (RBQM).
• The role of a Clinical Research Associate (CRA) and the transition from paper to electronic medical records.
• Insights into the importance of compliance, quality processes, and regulatory adherence in clinical trials.
• Fun and informative stories about working with cutting-edge technologies like oncolytic viruses and genetically modified organisms.

Key Takeaways:

• Understanding Compliance: Learn about the compliance funnel that blends regulations, company SOPs, and protocols to ensure patient safety and data integrity.
• The Power of Data: Discover how risk-based monitoring and quality management improve clinical trial efficiency and safety.
• Career Pathways: Teresa’s advice for aspiring professionals includes certifications, joining CRA programs, and building a robust LinkedIn profile.
• Networking and Growth: The importance of networking, volunteering, and staying updated with industry changes to advance your career in clinical research.

Episode Highlights:

• [0:01] Suzanne’s enthusiastic welcome and introduction of Teresa Davis.
• [0:30] Teresa’s career journey and the pivotal moments that shaped her path.
• [2:00] A deep dive into risk-based monitoring and quality management.
• [10:00] The transition from paper to electronic systems in clinical trials.
• [18:00] The importance of compliance, training, and documentation.
• [30:00] Teresa’s advice for breaking into the industry and growing your career.
• [40:00] Exciting advancements in personalized medicine and clinical research.

📞 Connect with Teresa:

• LinkedIn: www.linkedin.com/in/teresasuedavis
• Email: TeresaSueDavis08@Gmail.com

📞 Connect with Suzanne:

• Website: https://www.iceconsultingllc.com/home
• LinkedIn: https://www.linkedin.com/in/turnersuzannem/

💌 Feedback and Questions:

• Email Suzanne at podcast@iceconsultingllc.com

🎙️ Tune in and get to know the passionate professional behind Heart of the Trial!

Send us a Text Message.

Join the always energetic Suzanne Turner as she dives into the intricate world of drug safety with industry veteran Janet Cummins! With over 20 years of experience, Janet shares her journey from a high school vocational tech class to becoming a director in pharmacovigilance. Get ready for a whirlwind tour of what really goes on behind the scenes in clinical trials.

Janet brings a wealth of knowledge and a healthy dose of humor to topics like adverse events, regulatory requirements, and the unexpected twists and turns in drug development. Did you know that a hypertension study led to the creation of Viagra? Or that some participants in trials have had their stool samples sent all the way to Switzerland? These are just a few of the fascinating stories you'll hear.

In this episode, Suzanne and Janet discuss:

• The nitty-gritty of drug safety and pharmacovigilance.
• Janet’s unconventional path into the industry and her passion for ensuring drug safety.
• The importance of regulatory bodies like the FDA and their impact on clinical trials.
• Hilarious and surprising moments from Janet’s extensive career, including a clinical trial involving gas collection in jars!

Whether you're an industry insider or just curious about the human side of healthcare, this episode is packed with insights and entertainment. Janet’s enthusiasm and Suzanne’s engaging hosting style make for a compelling listen that sheds light on the dedicated professionals working tirelessly to ensure the safety of new medications.

So, buckle up for an informative and fun ride through the trials and tribulations of clinical research. Tune in to discover the heart of the trial!

✨ Episode Highlights:

• [0:02] Suzanne welcomes listeners and introduces Janet Cummins.
• [1:20] Janet’s career journey and the role of pharmacovigilance.
• [10:35] Real-life anecdotes from clinical trials.
• [18:50] The evolution of drug safety and its regulatory framework.
• [30:00] Hilarious trial stories – from fart jars to unexpected drug effects.
• [45:15] Closing thoughts and contact information for Janet Cummins.

📞 Connect with Janet:

• Email: Janet@JanetLKoontz.com or KoontzJL@gmail.com
• Linkedin: https://www.linkedin.com/in/janetlkoontz/
• Phone: 619-895-5439

📞 Connect with Suzanne:

• Website: https://www.iceconsultingllc.com/home
• LinkedIn: https://www.linkedin.com/in/turnersuzannem/

💌 Feedback and Questions:

• Email Suzanne at podcast@iceconsultingllc.com

🎙️ Tune in and get to know the passionate professional behind Heart of the Trial!