Clinical Operations Manager

About Denali:

Denali Health is a fast-growing clinical research organization focused on accelerating therapies to market through operational excellence, exceptional talent, and a participant-centered approach to research.

We are building a network of high-performing clinical research sites and fostering a culture of trust, accountability, ownership, and continuous improvement. Our goal is simple: deliver industry-leading results while creating meaningful opportunities for talented professionals to grow their careers.

Why This Role Matters:

Every successful clinical trial depends on operational excellence. The systems you build, the teams you lead, and the problems you solve directly impact participant enrollment, protocol compliance, data quality, and study execution.

As a Clinical Operations Manager at Denali Health, you'll help create the infrastructure that allows breakthrough therapies to reach patients faster. Your work will influence not just individual studies, but the growth and performance of an entire clinical research network.

What You'll Do:

Build and Optimize Site Operations:

• Design, implement, and continuously improve clinical research workflows that maximize enrollment, regulatory compliance, and data quality.
• Lead operational initiatives that expand study capacity, site capabilities, and therapeutic area expertise.
• Monitor and improve key site performance metrics, including:
• Enrollment rates
• Screen failure rates
• Protocol deviations
• Data query resolution timelines
• Sponsor satisfaction
• Identify operational bottlenecks and implement proactive solutions before they impact study execution.
• Travel regularly to research sites to assess performance, support teams, and drive continuous improvement.

Lead High-Performing Teams:

• Manage and develop site-based clinical and administrative staff.
• Build a culture of accountability, ownership, and operational excellence.
• Partner with site leadership, Principal Investigators, and research teams to align execution with organizational goals.
• Serve as a trusted problem solver during operational challenges and study escalations.
• Create scalable systems and processes that support growth across multiple sites.

Drive Clinical Research Excellence:

• Ensure exceptional participant experiences from screening through study completion.
• Maintain compliance with FDA regulations, ICH-GCP guidelines, sponsor requirements, and site SOPs.
• Implement quality improvement initiatives based on audits, inspections, sponsor feedback, and performance metrics.
• Support high-quality study execution through strong operational oversight and collaboration.
• Partner with sponsors, CROs, investigators, and coordinators to deliver successful studies.

Lead Strategic Projects:

• Own high-priority operational initiatives from planning through execution.
• Collaborate across departments to improve organizational performance.
• Introduce innovative ideas and drive implementation.
• Adapt quickly as priorities evolve in a dynamic clinical research environment.

You're a Good Fit If You Are:

• An owner who takes responsibility for outcomes.
• A builder who enjoys creating systems and improving processes.
• Resourceful and proactive when solving problems.
• Comfortable making decisions in fast-paced environments.
• Data-driven and focused on measurable results.
• Resilient under pressure.
• Collaborative and committed to helping teams succeed.
• Passionate about advancing clinical research and improving patient access to new therapies.

Must-Haves:

• 2–5+ years of progressive experience in clinical research, site management, healthcare operations, or a related field.
• Strong understanding of clinical research operations and site workflows.
• Working knowledge of FDA regulations, ICH-GCP guidelines, and sponsor expectations.
• Demonstrated experience improving operational performance and achieving measurable results.
• Strong analytical and project management skills.
• Experience managing multiple priorities simultaneously.
• Willingness and ability to travel regularly (30–50%).
• Ability to work hands-on within research sites rather than exclusively in a remote management capacity.

Nice-to-Haves

• Experience managing multi-site research operations.
• Experience with participant recruitment and enrollment strategy.
• Experience supporting site growth and expansion initiatives.
• Familiarity with CTMS, EDC, and research technology platforms.
• Experience leading quality improvement initiatives.
• Healthcare administration, business, or operations leadership experience.

How We'll Support Your Growth:

• Direct mentorship from experienced healthcare and research leaders.
• Exposure to multiple therapeutic areas, study phases, and site operations models.
• Continuing education support, certifications, conferences, and leadership development opportunities.
• Opportunities to lead increasingly complex operational initiatives.
• Clear pathways into senior operations leadership roles as Denali continues to grow.

Why Denali?

Do work that matters: Help bring life-changing therapies to patients faster.

Own your impact: Your decisions directly influence enrollment, quality, compliance, and growth.

Grow with purpose: Gain exposure to site operations, strategy, business development, and leadership.

Learn from exceptional people: Work alongside experienced investigators, executives, and clinical research professionals.

Build something meaningful: Join a rapidly growing organization where your ideas and execution shape the future of the company.

Advance your career: High performers have opportunities to grow into Director, VP, and executive leadership roles.

To Apply

Please email your resume to [email protected].