Four Pillars of My Success as a Clinical Trial Transparency Specialist

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Shawn Lantz, Senior Clinical Trial Transparency Specialist at MMS, discusses their successful career in clinical trial transparency, ensuring proper trial registration and result disclosure.

Careers in clinical trial transparency are rarely planned; they are discovered. A conversation with a friend one day in 2014 changed the course of my professional career as I was presented with a part time opportunity to be a redaction contractor for a contract research organization. Her invitation to explore this new world of clinical trial transparency (CTT) included words and phrases such as “ground-floor opportunity,” “specialized niche,” and “redacting submission documents.” Five minutes into our conversation, I was intrigued.

Years before, I had been accepted into nursing school, but life circumstances had led me in a different direction. My undergraduate degree was not one that had prepared me for this opportunity. I was deeply immersed in motherhood while quietly longing to be challenged intellectually again. Little did I know that accepting that unfamiliar opportunity would become one of the most meaningful professional decisions I have ever made.

Fast forward twelve years to 2026. Reflecting on the unconventional path I took into clinical trial transparency (CTT), becoming a successful clinical trial transparency specialist, I can clearly see four pillars that have supported my growth and success.

Pillar One: Clinical Trial Industry Mentorship

At the outset of my career in CTT, I had the privilege of learning from two exceptional mentors.

My first mentor was passionate and skilled in communicating new concepts evolving within clinical trial transparency. She was generous and patient. She focused on providing excellent training to help our team develop best practices that continue with me today. Her open-door policy provided a rich environment with a safe place to ask questions. One of the most memorable training resources she shared was a simple document that focused on where direct and indirect identifiers were most likely to appear in a clinical study report (CSR). This guide was invaluable at improving my efficiency in redaction as I learned the sections in which I should spend most of my time looking for redactable information. As we parted ways, she encouraged me to continue growing and learning.

My second mentor challenged me differently. She gave me opportunities to think strategically and hone my ability to have an eye for complex redaction approaches. She brought an attitude of problem solving to difficult situations that I have tried to emulate. Under her leadership, I learned how to listen to sponsors’ needs. When the European Medicines Agency temporarily suspended Policy 0070 in 2018, and Health Canada’s Public Release of Clinical Information (PRCI) emerged as a leading authority, my mentor helped our team navigate new transparency guidance. The confidence I developed under her leadership allowed me to offer our sponsors help in strategizing for risk assessment for their New Drug Submission (NDS) packages by attending the Process Initiation Meetings (PIMs) for Health Canada.

Even today, when I encounter a challenge, I always pause and ask myself: what would she do? That simple reflection often helps bring clarity and answers to complex or puzzling situations.

Pillar Two: Qualities of a Successful Transparency Specialists

Those interested in the exciting field of clinical trial transparency may be wondering what qualities and skills are needed for success in CTT. I have divided these into two areas of requirements: technical and soft skills.

Technical Strength

When explaining the qualities needed for success in CTT, I often liken them to a detective solving a mystery. A great detective must strike a delicate balance between not giving away confidential information about the case while exposing enough information to safeguard the public concerned. In the same way, those of us in CTT must work with our sponsors to discover what company proprietary information should remain undisclosed while satisfying the requirements for maximum data utility for the regulatory body and the public at large who may benefit from approved disclosed information. Having an eye for detail and delivering excellent quality are must-have skills. Understanding the scope of submission documents per the regulatory agency is a necessary skill for a successful transparency specialist. Experience in quantitative risk assessment involving anonymization techniques including generalization, suppression, offsetting and randomization has become necessary as regulatory agencies such as Health Canada encourage sponsors to rationalize anonymization approaches through structured risk assessment. Precision and structured thinking are foundational in transparency work.

Soft Skills

As one grows into more senior roles, soft skills become equally critical. Being able to establish trust with both colleagues and sponsors is vital for a successful submission. A transparency specialist should be comfortable leading a kickoff meeting to discuss scope of documents, anonymization approach (qualitative or quantitative), and timeline. Having confidence to ask clarifying questions will be called upon throughout the preparation of a submission for disclosure. Bringing a problem-solving attitude to the table and creative thinking are beneficial qualities to have for someone interested in a career in CTT. Surrounding oneself with knowledgeable colleagues with cross-functional expertise benefits all involved for the smooth process of sponsor submission preparedness for disclosure.

Pillar Three: Keeping the “Who” and “Why” Top of Mind

Early in my career, working as a contractor, I focused primarily on completing tasks. As I transitioned from a contractor to working full time roles within a contract research organization, the puzzle pieces began to come together revealing CTT’s purpose.

I came to understand that disclosure is not simply a regulatory requirement; it is an ethical responsibility. While anonymizing submission documents involving a rare disease, I have often thought of parenst who are desperate to find information on medicines that can improve or save their child’s life. CTT specialists support sponsors so that medical professionals, researchers, and informed members of the public can access meaningful information. At MMS, transparency is not a compliance exercise; it is a strategic function that integrates regulatory requirements, risk assessment expertise, and cross-functional collaboration. Our team partners with sponsors early in the development lifecycle to proactively prepare for disclosure, rather than reacting at the point of submission.

Pillar Four: Embracing Opportunity

Twelve years later, I see transparency not just as a profession, but as a responsibility. In a world that demands both innovation and accountability, clinical trial transparency stands at the intersection of science, ethics, and trust; I am proud to be part of that mission. Clinical Trial Transparency extends beyond document disclosure to include global trial registration and results reporting across worldwide registries. I have had the opportunity to work in both areas, making my understanding more well-rounded within the overall field. Regulations evolve. Expectations shift. Technologies advance. What remains constant is the need for thoughtful professionals who can adapt and grow. Looking back, I am grateful for that five-minute conversation with my friend twelve years ago that launched me into a deeply rewarding career in clinical trial transparency. It is gratifying to know that I am supporting sponsors in their efforts to bring life-transforming medicines to the public with the ultimate goal of positively impacting patients’ lives.

Together, these four pillars have helped me move from completing tasks to contributing strategically, partnering with sponsors to meet global expectations while protecting participants and maximizing data utility.

For anyone considering a path into CTT, know that the work is challenging, meaningful, and always changing, there is room to learn, to be mentored, and to make a real impact. If you stay curious, invest in quality, and keep the patient at the center of the work, you will be well positioned to grow alongside the science and regulations that drive our industry forward.