Director of Research Operations

Director of Research Operations

Clinical Research | Multi-Site Research Network

Position Summary

We are seeking an experienced Director of Research Operations to lead the day-to-day operational execution of a growing, multi-site clinical trials portfolio.

Reporting to the Vice President of Research, the Director will translate the organization’s research strategy and growth objectives into consistent, measurable operational execution across the clinical trials enterprise.

This role is responsible for the operational foundation of clinical trial delivery: ensuring studies move efficiently from award through startup, activation, recruitment, enrollment, conduct, and closeout; sites have the resources and support required to perform; operational teams work cohesively across functional areas; and leadership has clear visibility into performance, risks, and resource needs.

The Director will lead and coordinate the functional areas supporting clinical trial execution, including site operations, study startup and activation, regulatory operations, recruitment and enrollment, trial delivery and project management, research systems and training, and operational data and performance management.

This is an execution-focused leadership role. Enterprise research strategy, organizational growth strategy, executive and sponsor relationships, research portfolio development, financial and business oversight, quality governance, and expansion of new research service lines remain under executive research leadership. The Director of Research Operations will be responsible for ensuring that those strategic priorities are translated into effective day-to-day clinical trial operations.

The successful candidate will be a highly experienced clinical research operations leader who knows how to build structure, establish accountability, develop teams, solve operational problems, and create scalable processes without creating unnecessary bureaucracy.

Key Responsibilities

Lead Clinical Trial Operations

• Own the operational execution of the clinical trials portfolio from study award through closeout.

• Translate organizational priorities into clear operational plans, responsibilities, timelines, and performance expectations.

• Create consistent operating practices across centralized research functions and participating research sites.

• Maintain visibility into the health of the clinical trial portfolio, including startup progress, enrollment performance, operational milestones, staffing and workload, and significant risks or barriers.

• Ensure issues are identified early, assigned to the appropriate owner, escalated when necessary, and followed through to resolution.

Drive Site Performance & Operational Excellence

• Ensure research sites have the infrastructure, processes, staffing support, training, and centralized resources necessary to execute clinical trials successfully.

• Establish clear expectations for site performance and routinely evaluate operational readiness, workload, enrollment performance, study execution, and barriers to success.

• Partner with site and practice leadership to address operational challenges while maintaining appropriate accountability for performance.

• Balance network-wide standardization with the practical needs of individual practices, investigators, and studies.

• Identify opportunities to simplify processes, reduce duplication, and improve the experience of conducting research within participating practices.

Oversee Study Startup & Activation

• Drive efficient movement of studies from award through site activation.

• Ensure coordination of regulatory activities, site readiness, systems setup, training, investigator preparation, operational planning, and other startup requirements.

• Establish measurable startup expectations and monitor studies against those expectations.

• Identify recurring causes of activation delays and implement process improvements to address them.

Strengthen Recruitment, Screening & Enrollment

• Ensure effective operational processes for identifying, screening, and enrolling appropriate research participants.

• Coordinate centralized recruitment resources with site-based recruitment and clinical-practice workflows.

• Strengthen integration of clinical research into routine patient care so that investigators and clinical teams can effectively identify potential participants.

• Establish visibility into recruitment funnels and enrollment performance and ensure underperforming studies have actionable recruitment plans.

• Drive follow-through and accountability for enrollment initiatives.

Establish Strong Trial Delivery & Project Management

• Create consistent project-management standards across active studies.

• Ensure studies have appropriate operational plans, timelines, meeting structures, deliverables, action-item tracking, escalation pathways, and communication processes.

• Establish clear ownership of study activities and ensure commitments to sponsors, investigators, sites, and internal stakeholders are tracked through completion.

• Develop processes that allow leadership to identify studies requiring intervention before significant milestones are missed.

Integrate Regulatory Operations into Trial Delivery

• Ensure regulatory activities are effectively integrated into startup and ongoing study operations.

• Maintain efficient processes for submissions, essential-document management, investigator documentation, amendments, continuing reviews, and closeout activities.

• Ensure regulatory workload and timelines are visible within overall study planning.

• Partner with quality and compliance leadership to address operational findings and ensure corrective actions are translated into sustainable operational practices.

Optimize Research Systems, Technology & Training

• Ensure research technology supports efficient trial execution across the network.

• Drive effective adoption and utilization of clinical trial management, electronic source, electronic regulatory, recruitment, and other research platforms.

• Identify workflow or technology barriers that create unnecessary administrative burden and lead efforts to improve them.

• Ensure research staff receive appropriate onboarding, systems training, role-based training, and ongoing operational education.

• Identify opportunities to appropriately use technology, automation, data, and artificial intelligence to improve research operations.

Build Operational Visibility & Accountability

• Develop and maintain meaningful operational metrics related to study startup, enrollment, trial performance, site performance, staffing, workload, and delivery.

• Use data to identify trends, anticipate operational needs, and guide resource allocation.

• Establish regular operating reviews that move beyond reporting information to identifying decisions, owners, actions, and deadlines.

• Provide executive research leadership with concise, reliable visibility into operational performance, significant risks, resource requirements, and issues requiring executive intervention.

Lead & Develop the Research Operations Team

• Build a high-performing, collaborative research operations organization with clear responsibilities and accountability.

• Ensure functional teams operate as an integrated clinical trials organization rather than as independent operational silos.

• Develop leaders and team members who can independently solve problems, make appropriate decisions, and take ownership of outcomes.

• Evaluate workload and staffing requirements as the portfolio grows and recommend resource changes based on operational demand.

• Create a culture characterized by ownership, responsiveness, collaboration, transparency, and continuous improvement.

Decision-Making & Leadership Scope

The Director of Research Operations will have significant authority over the day-to-day execution of clinical trial operations and will be expected to independently make operational decisions within established organizational strategy, policies, budgets, and quality standards.

The Director will determine how operational resources are deployed, how workflows are structured, how operational issues are resolved, and when performance concerns require intervention or escalation.

The role will partner closely with executive research leadership on matters involving significant financial commitments, organizational strategy, sponsor or executive relationships, major staffing investments, research portfolio decisions, quality or compliance risk, and expansion into new research capabilities or service lines.

The expectation is not simply to identify operational problems for executive leadership to solve. The Director should arrive with an assessment, a recommended solution, and a plan for execution, escalating primarily when a decision requires executive authority or has broader organizational implications.

What Success Looks Like

Success in this role means the clinical research organization operates effectively and predictably as the research network grows.

Studies move from award to activation efficiently. Sites know what is expected of them and have access to the support they need. Recruitment opportunities are identified and acted upon. Enrollment performance is actively managed. Operational risks are identified early. Teams understand who owns what. Commitments are followed through to completion. Leadership can quickly understand the health of the portfolio.

Most importantly, day-to-day clinical trial operations do not require continuous executive intervention to move forward.

The Director creates the structure, leadership, operating discipline, and accountability that allow executive research leadership to remain focused on strategy, growth, partnerships, financial performance, organizational development, and the future direction of the research enterprise.

Qualifications

Required

• Extensive clinical research experience with progressive responsibility in research operations and leadership.

• Demonstrated experience overseeing clinical trial execution across multiple studies, sites, or research programs.

• Strong operational knowledge of study startup, regulatory processes, recruitment and enrollment, trial conduct, and study closeout.

• Experience leading teams and coordinating work across multiple functional areas.

• Demonstrated ability to build operational processes and establish accountability in a growing or changing organization.

• Strong understanding of Good Clinical Practice (GCP) and sponsor-supported clinical trial operations.

• Demonstrated ability to identify complex operational problems, develop practical solutions, and drive implementation through completion.

• Strong project-management, organizational, and prioritization skills.

• Ability to interpret operational data and use it to drive decisions and performance improvement.

• Strong leadership and communication skills with the ability to work effectively with investigators, research staff, clinical practices, sponsors, CROs, and executive leadership.

Preferred

• Experience within a multi-site clinical research organization, healthcare network, site network, or similarly distributed research environment.

• Experience building or scaling clinical research operations.

• Experience supporting cardiovascular or other complex therapeutic-area clinical trials.

• Experience implementing or optimizing centralized research services.

• Experience with clinical trial management systems, electronic source, electronic regulatory systems, recruitment technologies, and other research platforms.

• Experience developing operational dashboards, KPIs, and performance-management processes.

The Opportunity

This is an opportunity to take operational leadership of a growing clinical trials organization at an important stage in its development.

We have built the foundation. The next challenge is creating the operational structure and discipline that allow the organization to scale.

We are looking for a leader who can see both the individual trial and the operating system behind it — someone who can move comfortably between people, processes, sites, systems, and data; recognize where execution is breaking down; and then take ownership of fixing it.

The right person will not simply manage clinical research operations. He/she will build an organization that consistently delivers successful clinical trials.

Originally posted on Himalayas