• Collaborate on the redesign and optimization of end-to-end data management processes including study start-up, maintenance, and close-out. • Evaluate and revise existing procedures to align with internal execution capabilities, ensuring operational efficiency, compliance, and scalability. • Provide strategic oversight of functional improvements across data management operations. • Oversee and contribute to the reengineering and execution of critical data management functions, including: • Study Set-Up • EDC Build and Maintenance • Data Cleaning and Query Management • Local Laboratory and External Data Handling • Clinical Coding • SAE Reconciliation • Blinding Procedures • Site Close-Out and Database Lock • Data Management Metrics and Clean Patient Tracker oversight • Ensure all data management activities comply with applicable regulatory requirements, CDISC standards, and internal quality standards. • Support audit readiness, inspection preparedness, and continuous quality improvement initiatives. • Identify and mitigate data-related risks proactively. • Represent the Data Management function within the clinical trial working group. • Ensure aligned expectations for all data-related deliverables, especially those supporting regulatory submissions and key milestone decisions. • Collaborate closely with Clinical Operations, Statistical Programming, Biostatistics, and other stakeholders to ensure timely database lock and delivery of high-quality data. • Provide influential leadership to ensure milestones and deliverables are met within timelines and budget. • Contribute to continuous improvement initiatives at the functional and organizational levels.

The Principal Clinical Data Manager (Sponsor-Dedicated) works fully embedded within a global pharmaceutical client, serving as the lead data management representative across assigned clinical studies. This role is responsible for overseeing end-to-end clinical data management processes, driving process reengineering initiatives, ensuring regulatory compliance, and delivering high-quality data in support of key decision points and regulatory submissions. The position combines strategic leadership with hands-on data management execution. Responsibilities & Duties: Process Reengineering & Oversight - Collaborate on the redesign and optimization of end-to-end data management processes including study start-up, maintenance, and close-out. - Evaluate and revise existing procedures to align with internal execution capabilities, ensuring operational efficiency, compliance, and scalability. - Provide strategic oversight of functional improvements across data management operations. Functional Area Ownership Oversee and contribute to the reengineering and execution of critical data management functions, including: - Study Set-Up - EDC Build and Maintenance - Data Cleaning and Query Management - Local Laboratory and External Data Handling - Clinical Coding - SAE Reconciliation - Blinding Procedures - Site Close-Out and Database Lock - Data Management Metrics and Clean Patient Tracker oversight Quality & Compliance - Ensure all data management activities comply with applicable regulatory requirements, CDISC standards, and internal quality standards. - Support audit readiness, inspection preparedness, and continuous quality improvement initiatives. - Identify and mitigate data-related risks proactively. Clinical Trial Leadership & Cross-Functional Collaboration - Represent the Data Management function within the clinical trial working group. - Ensure aligned expectations for all data-related deliverables, especially those supporting regulatory submissions and key milestone decisions. - Collaborate closely with Clinical Operations, Statistical Programming, Biostatistics, and other stakeholders to ensure timely database lock and delivery of high-quality data. - Provide influential leadership to ensure milestones and deliverables are met within timelines and budget. - Contribute to continuous improvement initiatives at the functional and organizational levels.

• Explore data to identify trends and evaluate performance • Design, implement, and optimize algorithms • Build and refine predictive models • Collaborate with product/business teams • Conduct and evaluate A/B tests • Create dashboards and communicate findings

• Bring advanced understanding of the clinical data management process from study start-up through database lock. • Oversee the compliance activities across multiple CROs as it relates to data management. • Responsible for third party vendor oversight activities across global development programs. • Represents data management function ensuring aligned expectations between the CRO and client for all data related deliverables. • Contributes influential leadership in collaboration with other client Stakeholders. • Partners with appropriate stakeholders and CRO partners to mitigate and resolve risks. • Provides input to functional governance with client strategic suppliers. • Participates in preparing function for submission readiness and may represent function in a formal inspection or audit. • Ensures achievement of major data management deliverables and milestones in coordination with other functions.