In this edition of our Career Perspectives series, we are delighted to feature Naydene Slabbert, Principal Clinical Data Manager, at Cytel. Naydene shares insights from her career journey, discusses the critical role of early-stage clinical trial setup in ensuring the delivery of high-quality, actionable data, and reflects on the evolving role of data managers in clinical trials.
Can you give us a little background on your career so far? What led you to clinical data management, and how has your path evolved over the years?
My journey in clinical data management started over 23 years ago, and it’s been such a rewarding experience filled with growth, learning, and a lot of exciting challenges. I began my career at Quintiles (now IQVIA), where I started as an Assistant Data Coordinator and eventually became a Data Team Lead. Those early years gave me a solid foundation in clinical trial operations and sparked my interest in data quality and process improvement.
In 2021, I moved to DF/Net Research, where I led several high-profile studies and contributed to infrastructure and software development. That role helped me expand my technical and strategic skills, especially in managing complex, multi-site trials.
Now, I’m proud to be part of Cytel as a Principal Clinical Data Manager. My focus is on enhancing end-to-end data management processes, working closely with cross-functional teams, and making sure our systems support both scientific excellence and regulatory success. Over the years, my role has evolved from hands-on data work to strategic leadership, and I continue to be inspired by the impact that well-managed clinical data can have on public health and patient outcomes.
You’ve been supporting the lead on a major study that went live in September. What did your day-to-day work look like at this stage of the project?
During the go-live phase of the study I’m working on, my daily focus was to make sure our data management systems and processes were running smoothly and in sync across teams. It’s a crucial time where accuracy, quick thinking, and strong teamwork really matter.
I partnered closely with the study lead and various cross-functional teams to validate the Electronic Data Capture (EDC) system, double-checking that all edit checks and Case Report Forms (CRFs) were working as expected. We held daily huddles and status meetings to keep everyone aligned and moving forward, which made it easier to spot and tackle any issues early on.
This stage demanded a lot of agility, collaboration, and attention to detail — all with the goal of setting the study up for long-term success.
From preparing documents to getting the database ready for data collection — how do these early tasks set the foundation for a successful study?
The early stages of a clinical study really lay the groundwork for everything that follows. It’s where we take the scientific goals outlined in the protocol and turn them into practical, workable data processes. Getting this part right is key to the trial’s overall success.
A big part of this involves preparing core documents like the Data Management Plan, validation guidelines, and Standard Operating Procedures (SOPs). These aren’t just paperwork — they’re the playbook that keeps everyone aligned on exactly how data will be collected, reviewed, and reported. They help ensure consistency, compliance, and quality from start to finish.
At the same time, building and testing the database, from CRF design to edit checks and system integrations, is just as critical. This is where we make sure the tools for capturing data are user-friendly, accurate, and fully aligned with the protocol. A well-designed database helps reduce errors, speeds up query resolution, and supports faster decision-making.
By putting in time and care upfront, we’re able to minimize potential risks, boost efficiency, and set the stage for a study that’s not only regulatory-ready but also delivers high-quality, actionable data. In my experience, a strong launch phase really sets the tone for everything that follows.
Now the study has gone live, you’re overseeing the data. What does that oversight involve, and how do you ensure data quality and consistency throughout the trial?
Once a study goes live, my role shifts into a proactive oversight phase where the focus is on maintaining data integrity, consistency, and compliance across all participating sites and systems.
Ultimately, my goal is to create a system of continuous quality assurance. By fostering strong communication, leveraging technology for real-time insights, and maintaining rigorous documentation, I help ensure that the data collected is accurate, timely, and meaningful. This supports both scientific outcomes and regulatory success, and ultimately, the patients.
What do you like best about your role, and about working at Cytel?
What I enjoy most about my role is the opportunity to lead complex studies that have real-world impact, while collaborating with talented teams across disciplines. I thrive on problem-solving and ensuring data quality from start to finish, and I appreciate the autonomy and trust I’m given to manage projects effectively.
As for Cytel, I value the supportive culture and global collaboration. The company encourages continuous learning and innovation, and I’ve found the environment to be both respectful and intellectually stimulating. It’s rewarding to be part of an organization that’s committed to advancing clinical research through data-driven solutions.
Is there a particular project or initiative you’ve worked on recently that you’re especially proud of?
One project I’m especially proud of is the trial I mentioned earlier, which went live recently. It’s a high-profile study with complex data requirements, and I’ve been deeply involved from the early planning stages through to go-live. I helped translate the protocol into robust data collection tools, oversaw database setup and testing, and now manage ongoing data oversight. What makes this project stand out is the level of collaboration and precision required. It’s been incredibly rewarding to see our preparation pay off in a smooth launch!
You’ve held leadership roles across several organizations. What’s one piece of career advice you wish you had received earlier?
If I could go back and give myself one piece of advice early in my career, it would be: “Don’t shy away from getting your hands dirty.” I used to think leadership was mostly about strategy and oversight, but some of the most valuable lessons, and the biggest impacts made, came from jumping into the details.
Whether it’s troubleshooting a tricky data issue, reviewing CRFs, or helping build out a database, being hands-on keeps you sharp and connected to the work. It also builds trust with your team. They can see you’re not just directing from the sidelines, but genuinely in it with them. That kind of involvement helps you lead with more empathy, insight, and credibility.
How has your approach to managing clinical data changed over time, especially as you’ve moved into more strategic roles?
Over time, my approach to managing clinical data has shifted from task execution to strategic oversight. Early in my career, I focused on operational details such as CRF design, data cleaning, and query resolution. As I moved into leadership roles, I began shaping data strategies, aligning them with protocol goals, regulatory requirements, and sponsor expectations. I now prioritize proactive planning, cross-functional collaboration, and system optimization to ensure data quality and efficiency across the entire study lifecycle.
Now, my approach is focused on seeing the bigger picture and guiding teams toward smarter, scalable solutions.
Clinical trials can be complex, especially when managing data across different regions and systems. What are some of the biggest challenges you’ve faced in data management, and how did you tackle them?
One of the biggest challenges in clinical data management is keeping data consistent and reliable across multiple regions, especially in large, global studies. Each site often has its own workflows, varying levels of experience, and different infrastructure, which can lead to inconsistencies in how data is captured and handled.
To manage this, I focus on creating clear, well-structured documentation and providing centralized training to ensure everyone is on the same page. I also put strong validation processes in place to catch issues early. Working closely with vendors and site teams is key — it allows us to resolve problems in real time and keep the data aligned across systems.
Strategic planning and open communication play a big role too. By staying connected with all stakeholders and anticipating potential challenges, we’re able to maintain high-quality, harmonized data throughout the trial. It’s all about building trust, being proactive, and keeping the bigger picture in mind.
The field is evolving quickly. How do you see the role of data managers changing with the rise of AI, machine learning, and decentralized trials?
The role of data managers is indeed evolving rapidly with the rise of AI, machine learning, and decentralized trials. We’re moving from purely operational roles to more strategic ones, where we not only manage data but also help shape how it’s collected, interpreted, and used.
One trend I’m particularly excited about is the integration of AI and machine learning into data cleaning and query management. These tools help us move from reactive to proactive data oversight, identifying patterns and anomalies much earlier in the process. Decentralized trials are also reshaping how we collect and manage data — requiring more flexible systems and real-time validation strategies. As a data manager, I now focus more on system integration, data governance, and ensuring that new technologies align with regulatory standards and study goals.
These innovations are pushing us to become more strategic, tech-savvy, and collaborative, which I find both challenging and energizing. It’s an exciting shift that requires both adaptability and a strong foundation in data quality principles.
What skills do you think will be essential for future data managers entering the field?
I think future professionals in this space will need a mix of technical know-how, strategic thinking, and flexibility to really thrive.
For starters, being comfortable with data, understanding how to interpret it, analyze it, and use tools that support automation and predictive insights, is going to be key. With AI, machine learning, and real-time data becoming more common, data managers will need to be confident working with more complex systems and datasets.
Technical skills will always be important. You’ll still need to work with EDC platforms, understand coding and data standards, and know how to manage data integrations. But we’re also seeing a growing need to understand APIs, interoperability, and data governance, especially as decentralized trials become more widespread.
Just as important are the soft skills. Strong communication, collaboration, and leadership are essential because data managers often act as the link between clinical, statistical, and operational teams. Being able to bring people together and keep everyone aligned makes a huge difference.
And finally, I’d say curiosity and a willingness to keep learning are vital. The field is changing fast, and those who stay open to new ideas and keep building their skills will be best positioned to lead the way.
As a remote employee, how do you maintain a healthy work-life balance? What strategies work for you, and do you feel supported by Cytel in this regard?
Working remotely definitely has its perks, but maintaining a healthy work-life balance takes a bit of intention. For me, it starts with having a clear plan for the day. I like to set goals, block out time for focused work, and make sure I take regular breaks. I also try to stick to a consistent “log-off” time, which helps me mentally switch from work mode to personal time.
One thing that’s really helped is having a dedicated workspace that’s separate from my living space. It makes it easier to stay focused during the day and disconnect in the evenings. I also make time for walks, family, and activities that help me recharge as those are just as important as meetings and deadlines.
Cytel has been incredibly supportive when it comes to flexibility and balance. There’s a lot of trust and autonomy, and the culture really respects personal time. Leadership encourages us to take care of ourselves, which makes remote work not only manageable but genuinely enjoyable.
You have been with Cytel for around 6 months now. What aspects of Cytel’s culture stood out to you when you joined?
What really stood out for me when I joined Cytel was how collaborative and welcoming the culture is. From day one, I felt like part of a team. People are generous with their time, open to new ideas, and genuinely invested in working together to achieve shared goals. It’s not just about getting the job done; it’s about how we support each other along the way.
I also really appreciate the company’s focus on quality and innovation. There’s a strong drive for continuous improvement, and strategic thinking is encouraged. That’s something I value deeply in my own work, especially when it comes to refining processes and contributing to cross-functional initiatives.
Another thing that impressed me is how well remote employees are supported. Even though I’m based in South Africa, I’ve felt fully connected to the global team. Communication is seamless, and there’s a real effort to make sure remote staff feel included and empowered.
Overall, Cytel fosters a culture that supports both professional growth and personal well-being, and that’s something I truly appreciate.
Finally, what are your main interests outside of work? What helps you recharge and stay inspired?
When I’m not working, you’ll probably find me out in the beautiful South African bushveld, book in hand, or enjoying coffee in the sun — my personal reset button. I love getting creative in the kitchen (even if some dinners end up as “learning experiences”) and tackling home improvement projects just for the fun of it.
I’m also a mom to teenagers, which means my life is a mix of deep chats, dramatic eye rolls, and trying to keep up with slang that changes weekly. They keep me laughing, grounded, and constantly on my toes.
Spending time with family and friends is what really recharges me. It’s the fuel that keeps everything else running smoothly.
Thank you, Naydene, for sharing your experience with us!
Naydene Slabbert
