Director, Clinical Technical Operations

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

📋 Description

• Execute Clinical Technical Operations strategies and priorities that align with corporate and Clinical Management goals.

• Contribute to advancements in clinical technologies, digital innovation, system integrations, automation, and data management capabilities.

• Act as a subject matter expert and vital partner on emerging technologies, industry trends, and best practices.

• Lead initiatives for implementation and optimization aimed at enhancing study execution, operational efficiency, data quality, inspection readiness, and user experience.

• Engage in governance processes regarding clinical systems, technology investments, prioritization, and change management.

• Provide strategic oversight for the implementation, optimization, validation, maintenance, and lifecycle management of clinical systems including CTMS, eTMF, Master Data Management tools, digital trial technologies, study start-up systems, and clinical analytics/reporting platforms.

• Ensure integration and interoperability between internal and external systems that support clinical operations.

• Establish governance standards for systems, performance expectations, and frameworks for continuous improvement.

• Develop and manage clinical operational data governance frameworks.

• Promote standards for data stewardship, ownership, quality, retention, security, and lifecycle management.

• Supervise clinical data flows, integrations, data mappings, and system architecture.

• Ensure thorough documentation of data flow diagrams, system architecture, and business process maps.

• Advocate for operational analytics, business intelligence, dashboards, and predictive metrics.

• Collaborate with Clinical Operations leadership to facilitate efficient and compliant study execution throughout all phases of clinical development.

• Assess trial execution challenges and performance metrics to pinpoint technology-enabled improvements.

• Implement and enhance risk-based quality management and monitoring approaches.

• Support the standardization of clinical operational processes, SOPs, work instructions, and best practices.

• Identify and mitigate operational risks that may affect timelines, quality, budget, and patient safety.

• Establish dashboards, KPIs, KRIs, and performance metrics for overseeing portfolios and assessing study health.

• Drive operational inspection readiness through documentation, quality metrics, issue management, and compliance processes.

• Lead initiatives for workflow automation, process simplification, and digital enablement.

• Direct cross-functional project teams for technology implementation, organizational change, and process transformation.

• Recommend technology investments, operational models, and resource allocation.

• Ensure the implementation, adoption, and optimization of new technologies.

• Maintain compliance with global regulatory requirements and standards.

• Collaborate with Quality Assurance and Information Technology to uphold validated and compliant systems.

• Prepare for internal audits, regulatory inspections, and vendor assessments.

• Lead the investigation and resolution of technology-related quality issues, audit findings, and CAPAs.

• Define, monitor, and report metrics related to system utilization, data quality, operational efficiency, user adoption, and technology ROI.

• Present operational performance, risks, and opportunities for improvement to senior leadership and governance committees.

• Develop executive dashboards and reporting frameworks.

• Lead and nurture the Clinical Technical Operations team through guidance, coaching, mentoring, succession planning, goal setting, and professional development.

• Assist in workforce planning and enhancing organizational capabilities.

⛳️ Requirements

• Bachelor's degree in Life Sciences, Clinical Research, Nursing, Pharmacy, Public Health, Information Systems, or a related field.

• At least 12+ years of experience in pharmaceutical, biotechnology, or CRO environments supporting clinical operations.

• Minimum of 10+ years of leadership experience managing teams, programs, or complex cross-functional initiatives.

• Extensive knowledge of clinical trial technologies and digital platforms, including CTMS, eTMF, EDC, IRT, eCOA/ePRO, and similar systems.

• Proven expertise in comprehensive clinical trial operations, encompassing study start-up, site activation, enrollment management, monitoring oversight, study closeout, and inspection readiness.

• Strong grasp of Clinical Operations functional processes, metrics, and operational risk management methodologies.

• Experience in utilizing clinical operational metrics, key risk indicators (KRIs), and performance dashboards.

• Familiarity with clinical development processes across Phase I–IV studies and global clinical trial execution models and regulations.

• Solid understanding of inspection readiness expectations and quality management principles.

• Demonstrated success in leading technology implementation, digital transformation, and process improvement initiatives at an organizational level.

• Experience with system integration strategies, operational data governance, and enterprise architecture concepts.

• Proven experience in overseeing CROs, clinical vendors, and strategic service providers within a regulated clinical development environment.

• Ability to influence senior stakeholders and foster cross-functional alignment.

• Exceptional leadership, communication, project management, and strategic planning skills.

• Proficient in Microsoft Office applications and business intelligence/reporting tools.

• Willingness to travel as needed.

• Preferred: advanced degree (MS, MBA, MPH, or equivalent).

• Preferred: previous experience in Clinical Operations leadership, Study Management, Clinical Program Management, or Clinical Trial Management.

• Preferred: experience in supporting hybrid and technology-enabled clinical trial models.

• Preferred: experience in developing clinical operations performance frameworks and portfolio-level operational reporting.

• Preferred: experience in supporting complex global clinical development programs.

• Preferred: experience with enterprise data governance, business intelligence, analytics platforms, and automation technologies.

• Preferred: experience in leading organizational change management initiatives and large-scale technology deployments.

• Preferred: relevant certifications in project management, clinical research, information systems, or quality management.

🏝️ Benefits

• Comprehensive medical, dental, vision, and prescription drug coverage.

• Company-provided basic life insurance.

• Accidental death and dismemberment insurance.

• Short-term and long-term disability insurance.

• Tuition reimbursement.

• Student loan assistance.

• Generous 401(k) match.

• Flexible time off.

• Paid holidays.

• Paid leave programs.

• Other company-provided benefits.

• Incentive opportunity.