Invest In This One Thing To Help Strengthen Your ClinOps Team

By Melody Keel, founder and CEO, The Research Associate Group

After nearly two decades in clinical operations, I've seen our industry evolve in remarkable ways. What once began as paper-based trials with stacks of three-part case report forms has transformed into streamlined electronic data capture systems that allow for real-time monitoring and data cleaning. Trial master files that once occupied entire rooms of filing cabinets now exist in secure electronic environments, accessible to team members across the globe with appropriate permissions.

Beyond the technological shifts, our approach to monitoring has fundamentally changed, moving from 100% source data verification to risk-based approaches that prioritize critical data points. Patient recruitment has evolved from site-centric models to innovative direct-to-patient strategies leveraging social media and digital platforms. Regulatory interactions that once required physical submissions of thousands of pages now flow through electronic gateways, accelerating timelines and improving transparency.

Perhaps most significantly, the patient voice has risen to prominence, with patient reported outcomes, engagement initiatives, and decentralized trial models putting participants at the center of the research process rather than merely subjects within it.

Yet one aspect remains stubbornly unchanged: our approach to the people who power our clinical trials. As we face unprecedented transformation in how trials are conducted from the rapid adoption of decentralized trial models accelerated by the pandemic, to the integration of AI in protocol design and data analysis, to the emergence of platform trials accommodating multiple treatment arms with adaptive designs, the organizations that will thrive aren't just those with cutting-edge technology, they're the ones investing in their people today.

A Seismic Shift Is Coming

Let's be honest about where we stand. Decentralized trials, AI-driven data management, and patient-centric approaches aren't just buzzwords anymore; they're rapidly becoming our reality. But here's what many leaders miss: these innovations are only as effective as the teams implementing them.

I've seen firsthand how organizations with modest technology but exceptional teams outperform those with advanced systems but disengaged staff. The clinical operations landscape is shifting beneath our feet, as traditional site monitoring gives way to risk-based approaches that demand critical thinking rather than checkbox compliance. Study startup processes are compressing from months to weeks, requiring nimble teams who can troubleshoot in real-time. Protocol amendments, long ago considered exceptional events, have become routine challenges that ClinOps teams must navigate while maintaining study integrity and timeline adherence. Site relationships have evolved from transactional oversight to strategic partnerships requiring sophisticated relationship management skills. Clearly, the foundation that will keep companies standing isn't digital, it's human.

Reimagining Team Structures

The traditional clinical operations hierarchy, with its rigid reporting lines and siloed responsibilities, simply can't respond quickly enough to today's challenges. Imagine a critical protocol amendment that requires immediate implementation across 35 global sites. The clinical trial associate identifies an issue but must first report to their line manager, who escalates to the study manager, who then consults with data management, which operates under a different reporting structure entirely. Meanwhile, regulatory affairs, working in their own silo, remains unaware of the timeline implications until the formal cross-functional meeting scheduled for the following week. By the time all departments are aligned, precious weeks have been lost, and senior leadership is frustrated that the amendment strategy is delayed. Forward-thinking organizations are already exploring more adaptive models:

• Empowered cross-functional teams with clear accountability
• Flexible structures that deploy talent where it's needed most
• Agile methodologies tailored specifically for clinical research
• Mentorship programs that transfer knowledge while building capabilities

Research by the Association of Clinical Research Professionals (2023) shows that teams with strong mentorship programs experience 25% lower staff turnover than the industry average. This isn't just moving boxes on an org chart. It's fundamentally changing how we think about getting work done in clinical operations.

Beyond Box-Checking Efficiency

Too often, "process improvement" in our industry means cutting costs without considering the human impact. True operational excellence puts people at the center, asking:

• Does this process empower our teams or burden them? Replacing a 15-page site initiation report template with a streamlined form that focuses on critical findings can reduce documentation time considerably.
• Are we creating space for innovation or just demanding more output? Allocating protected time for CRAs to contribute to process improvement initiatives could be a better use of time than continuously increasing their monitoring visit quotas.
• Have we eliminated meaningless administrative tasks? Automating routine data reconciliation tasks that previously significantly consumed clinical data managers' time can allow them to focus on complex data trends and quality issues.
• Do our teams have what they need to succeed? Investing in specialized therapeutic area training for CRAs managing complex oncology trials can enable them to have more meaningful scientific discussions with investigators instead of simply verifying data collection.

When we optimize with people in mind, not just metrics, we create sustainable efficiency that drives trial success.

The Foundation: Supportive Culture

I've worked with dozens of clinical operations teams, and I can tell you unequivocally: culture trumps process every time. The organizations that will lead tomorrow's clinical research are investing today in:

• Cultures where teams feel safe taking calculated risks. A CRA identifying a potential quality issue at a high-performing site might be commended for flagging it early, not penalized for creating "extra work" or disrupting enrollment targets.
• Environments that celebrate both learning and achievement. A company might acknowledge a study team's innovative approach to resolving a complex protocol deviation as enthusiastically as they celebrate meeting last patient out milestones.
• Leadership approaches that focus on developing people, not just managing timelines. A ClinOps director might schedule regular career development discussions with team members, even during the intense database lock period, signaling that professional growth doesn't pause during critical study phases.
• Workplaces where professionals feel valued beyond their output. An organization might recognize a clinical project manager's mentorship of junior staff as a key performance indicator, not just their ability to keep studies on budget and timeline.

These aren't soft, nice-to-have elements. They're the bedrock of operational excellence in an industry where innovation isn't optional.

The Business Case Is Clear

  For the executives questioning the ROI on people and culture investments, my years in the field have shown consistently that investing in teams yields measurable returns:

• Teams that feel valued deliver higher-quality work. A clinical data management team with strong leadership support identified 30% more protocol deviations during routine review than their counterparts at sites with high turnover, preventing potential database lock delays.
• Experienced, engaged teams identify risks before they become problems. A seasoned study manager anticipated enrollment challenges at specific sites based on previous experience and proactively implemented mitigation strategies, keeping monthly enrollment targets within range while similar trials fell behind.
• Cohesive teams navigate challenges without falling apart. When a critical specialty vendor unexpectedly closed mid-study, a well-integrated operations team seamlessly redistributed responsibilities and maintained continuity while a comparable study at another company lost six weeks to transition chaos.
• Culturally strong organizations attract and retain top talent. A small biotech with a dedicated CRA Success Support program maintained CRA retention rates nearly double the industry average during the post-pandemic talent shortage, avoiding the high replacement costs per position.

These factors directly impact what matters most: getting safe, effective treatments to patients faster. A survey by PwC (2022) found that organizations, in general,  with highly engaged employees are 21% more profitable and exhibit 17% higher productivity than those with disengaged employees.

Starting Your Transformation Today

While comprehensive change takes time, you can begin laying the foundation immediately:

1. Honestly assess your current state. How are your teams structured? Do your people feel empowered? Is your culture supporting or hindering excellence? Is there a mechanism in place to capture team feedback via surveys, formal communication sessions, etc.?
2. Identify your capability gaps. What skills will your teams need to thrive in the evolving landscape? Where are you vulnerable?
3. Create your blueprint for transformation. Develop a road map that puts people first, builds a supportive culture, and then optimizes processes accordingly.

The Choice Ahead Of Us

The clinical operations teams that will excel in the coming years aren't just adapting to change, they're driving it. They're built on the foundations of empowered people, supportive cultures, and efficient processes. The organizations that recognize and act now will find themselves leading our industry. Those who continue treating people as interchangeable resources will increasingly find themselves struggling to keep pace.

About The Author:

Melody Keel is the founder and CEO of The Research Associate Group, with nearly two decades of experience transforming clinical operations through people-first approaches. Connect with Melody on LinkedIn to discuss strategies for elevating your clinical operations team's performance.