Director of Research Operations

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the daily operational implementation of the clinical trials portfolio from the award of the study through to its closeout.

• Convert organizational priorities into actionable operational plans, defining responsibilities, timelines, and performance expectations.

• Establish uniform operating practices across centralized research functions and collaborating research sites.

• Track startup progress, enrollment metrics, operational milestones, staffing levels, workload, and potential risks.

• Ensure that issues are appropriately assigned, escalated when needed, and effectively resolved.

• Confirm that sites are equipped with the necessary infrastructure, processes, staffing support, training, and centralized resources for successful trial execution.

• Propel study startup and site activation, which includes managing regulatory activities, systems setup, training, investigator preparation, and operational planning.

• Enhance participant recruitment, screening, and enrollment processes.

• Set up project-management standards, operational plans, timelines, deliverables, action-item tracking, escalation pathways, and communication strategies.

• Incorporate regulatory operations into the startup phase and continuous trial delivery.

• Streamline clinical trial management, electronic source documentation, electronic regulatory processes, recruitment, and other research platforms.

• Ensure comprehensive onboarding, systems training, role-based training, and ongoing operational education.

• Create operational metrics, dashboards, operating reviews, and accountability frameworks.

• Provide executive research leadership with insights into performance, risks, resource needs, and issues that need intervention.

• Assemble and nurture a high-performing research operations team, assessing staffing requirements as the portfolio expands.

• Make operational decisions that align with established strategies, policies, budgets, and quality standards.

⛳️ Requirements

• Extensive experience in clinical research with increasing responsibilities in research operations and leadership roles.

• Proven track record of managing clinical trial execution across various studies, sites, or research programs.

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

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

• Proven capability to develop operational processes and establish accountability in a dynamic or growing organization.

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

• Demonstrated ability to identify complex operational challenges, devise practical solutions, and drive implementation to completion.

• Excellent project management, organizational, and prioritization skills.

• Ability to analyze operational data and utilize it to inform decisions and enhance performance.

• Strong leadership and communication skills, capable of collaborating effectively with investigators, research staff, clinical practices, sponsors, CROs, and executive leadership.

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

• Preferred: Experience in developing or scaling clinical research operations.

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

• Preferred: Experience in implementing or optimizing centralized research services.

• Preferred: Familiarity with clinical trial management systems, electronic source documentation, electronic regulatory systems, recruitment technologies, and other research platforms.

• Preferred: Experience in developing operational dashboards, KPIs, and performance management processes.

🏝️ Benefits

• Flexible remote work arrangement.