Senior Manager, Clinical Technical Operations

Job Summary:

The Senior Manager, Clinical Technical Operations within Clinical Operations is responsible for supporting the implementation, integration, and optimization of technical systems and processes that support the planning, execution, and oversight of clinical trials. This role bridges the gap between clinical operations and technical functions, ensuring that digital tools, platforms, and data systems are effectively leveraged to drive operational efficiency, compliance, and data integrity.

The Senior Manager will collaborate cross-functionally with Clinical, Data Management, IT, Quality, and external vendors to support system implementation, process automation, and continuous improvement initiatives. This role also includes oversight of technical service providers and may involve line management responsibilities.

• Support the implementation, configuration, and maintenance of clinical operations systems (e.g., CTMS, eTMF, EDC, eCOA, IRT).
• Serve as a subject matter expert (SME) for clinical systems, ensuring alignment with regulatory requirements, operational needs, and data governance standards.
• Oversee system integrations in accordance with organizational architecture and compliance frameworks.
• Manage implementation of data transfers between internal systems and external vendor platforms, ensuring data accuracy, consistency, and compliance with applicable regulations.
• Lead the development and maintenance of data flow diagrams and technical documentation to support system architecture transparency, audit readiness, and cross-functional understanding.
• Champion data stewardship by promoting best practices in data quality, ownership, lifecycle management, and ensuring that clinical data is managed as a strategic asset across the organization.
• Collaborate with IT and system vendors to troubleshoot issues, manage upgrades, and ensure system validation and compliance.

• Identify opportunities to streamline clinical management activities through technology and process automation.
• Lead initiatives to enhance workflow efficiency, data accuracy, and system interoperability.
• Develop and maintain SOPs, work instructions, and training materials related to technical systems and processes.

• Partner with Clinical Management, IT, Data Management, and other applicable functions to align technical solutions with business objectives.
• Support cross-functional teams in the implementation, testing, adoption and effective use of clinical systems and tools.
• Support development of user training, onboarding, and change management for new technologies and processes to ensure successful system adoption.

• Oversee technical service providers and vendors supporting clinical systems and tools.
• Participate in vendor selection, contract negotiations, and performance monitoring.
• Ensure vendors meet service level agreements (SLAs), compliance standards, and project timelines.

• Ensure data integrity, security, and compliance with GCP, ICH, 21 CFR Part 11, and other applicable regulations.
• Support audits and inspections by providing system documentation, access logs, and validation records, as applicable.
• Collaborate with applicable business stakeholders, QA, and IT to maintain audit readiness and implement corrective actions as needed.

• Define and track key performance indicators (KPIs) related to system usage, data quality, and operational efficiency.
• Generate reports and dashboards to support decision-making and continuous improvement.
• Present technical findings and recommendations to leadership and cross-functional stakeholders.
• People Management (as applicable)
• Provide leadership, coaching, and development for direct reports.
• Oversee workload allocation, performance management, and professional growth of team members.
• Foster a culture of accountability, innovation, and continuous learning.

Required:

• Bachelor’s degree in life sciences, information systems, or a related field (advanced degree preferred).
• Minimum of 6 years of…