Director, Clinical Technical Operations

Director, Clinical Technical Operations

The Director, Clinical Technical Operations provides leadership and oversight for the technology ecosystem that supports global clinical trial programs. This role is responsible for executing the Clinical Management technology strategy, ensuring that clinical systems, digital processes, data governance frameworks, and technology-enabled capabilities effectively support the planning, execution, oversight, and inspection readiness of clinical trials.

The Director serves as a key business partner across applicable internal business functions and external service providers. The role leads operational excellence, technology transformation, and data-driven decision-making through the implementation and optimization of clinical technologies, integrated platforms, automation solutions, and clinical operational data initiatives. In addition to technology leadership responsibilities, the role provides expertise and guidance in clinical trial operations to ensure technology investments effectively support study planning, execution, quality oversight, risk management, and successful delivery of clinical development programs.

This individual leads a team of Clinical Technical Operations professionals and contributes to strategic vendor relationships, technology roadmaps, governance committees, and cross-functional initiatives to ensure compliant, scalable, and effective and scalable clinical operations capabilities.

Key Responsibilities:

• Execute Clinical Technical Operations plans and priorities aligned with corporate and Clinical Management objectives.
• Contribute to development and execution of clinical technologies, digital innovation, system integrations, automation, and data management capabilities.
• Serve as a subject matter expert for and key partner on behalf of Clinical Management on emerging technologies, industry trends, and best practices associated with utilization of associated technologies.
• Lead implementation and optimization initiatives in support of digital transformation to improve study execution, operational efficiency, data quality, inspection readiness, and user experience.
• Participate in governance processes for clinical systems, technology investments, prioritization, and change management.

Clinical Systems & Platform Oversight:

• Provide strategic oversight for the implementation, optimization, validation, maintenance, and lifecycle management of clinical systems, including but not limited to: CTMS, eTMF, Master Data Management tools, digital trial technologies, study start-up systems, Clinical analytics and reporting platforms.
• Ensure seamless integration and interoperability across internal and external systems supporting clinical operations.
• Establish system governance standards, performance expectations, and continuous improvement frameworks.
• Partner with IT and business stakeholders to ensure systems remain scalable, secure, compliant, and fit for purpose.

Data Governance, Architecture & Analytics:

• Establish and oversee data governance frameworks supporting clinical operational data.
• Drive enterprise standards for data stewardship, ownership, quality, retention, security, and lifecycle management.
• Provide strategic oversight of clinical data flows, integrations, data mappings, and system architecture.
• Ensure documentation of data flow diagrams, system architecture, and business process maps to support operational transparency, compliance, and audit readiness.
• Champion the use of operational analytics, business intelligence, dashboards, and predictive metrics to support data-driven decision-making.
• Collaborate with Data Management, Biostatistics, IT, and other applicable stakeholders to advance integrated data strategies.

Clinical Operations Excellence & Trial Execution:

• Serve as a strategic partner to Clinical Operations leadership to ensure technology solutions support efficient and compliant study execution across all phases of clinical development.
• Maintain deep understanding of clinical trial conduct, including study start-up, enrollment, monitoring, issue management, data review, study closeout, and inspection readiness activities.
• Evaluate operational performance metrics and trial execution challenges to identify opportunities for technology-enabled improvements in study delivery.
• Ensure clinical systems and data strategies align with operational needs for site management, enrollment forecasting, protocol execution, monitoring effectiveness, risk management, and study timelines.
• Partner with Clinical Operations teams to implement and optimize risk-based quality management (RBQM) and risk-based monitoring (RBM) approaches.
• Support development and standardization of clinical operational processes, SOPs, work instructions, and best practices across global clinical programs.
• Facilitate proactive identification and mitigation of operational risks impacting study timelines, quality, budget, and patient safety associated with technology utilization.
• Collaborate with study teams to…