Clinical Data Manager Jobs

About The Position

Requirements

• Bachelor's degree in Life Sciences, Computer Science, Statistics, Data Science, Information Systems, or a related field with 8 or more years of relevant experience; alternatively, a master's degree with 6 or more years of relevant experience.
• At least 2 years of experience managing professional associates.
• Demonstrated experience leading and developing Clinical Data Management and/or Statistical Programming professionals.
• Advanced knowledge of 21 CFR Part 11, Good Clinical Practice, and industry best practices for EDC and clinical data systems, with the ability to translate regulatory and quality requirements into practical, risk-based processes.
• Advanced understanding of the clinical study lifecycle, including study design, conduct, management, and data analysis.
• Working knowledge of SAS statistical programming practices sufficient to manage, review, and oversee programming deliverables.
• Working knowledge of AI and machine learning concepts and their application in clinical data management and clinical trial systems.

Nice To Haves

• Master's degree.
• Experience in diagnostics, in vitro diagnostics, medical devices, or another regulated life-sciences environment.
• Experience leading Clinical Data Management and/or Statistical Programming in clinical trials or a regulated life-sciences environment.
• Experience leading the selection, implementation, validation, administration, or governance of clinical technology platforms such as EDC/CDMS, CTMS, or eTMF.
• Experience evaluating or applying AI-enabled tools to clinical data management, clinical systems, or clinical documentation, with understanding of validation, data integrity, privacy, human oversight, and regulatory considerations.

Responsibilities

• Provide strategic and operational leadership for Clinical Data Management and Statistical Programming, aligned with Clinical Affairs and organizational objectives.
• Recruit, develop, and retain high-performing teams and foster accountability, collaboration, and continuous improvement.
• Set team goals, performance metrics, operating processes, and resource plans; manage budgets, priorities, and resources across studies, programs, and technology initiatives.
• Partner with senior leadership and cross-functional stakeholders to align priorities, mitigate risks, and support study execution.
• Oversee vendor evaluation, selection, contracting, and performance management for Clinical Data Management, Statistical Programming, and Clinical Affairs technology partners.
• Drive process improvements that enhance operational efficiency, quality, and scalability.
• Lead Clinical Data Management activities from study startup through database lock and close, ensuring accurate, complete, and reliable clinical data.
• Direct development and execution of Data Management Plans, edit-check specifications, reconciliations, external data transfers, and related documentation.
• Oversee database design, eCRF development, query management, coding, data review, and database validation.
• Lead user acceptance testing, system validation, and database release activities to ensure compliant, fit-for-purpose databases.
• Establish and maintain data standards, quality controls, and processes that promote data integrity, traceability, and inspection readiness.
• Lead Statistical Programming and oversee development, validation, review, and quality control of datasets, programming specifications, analyses, and study deliverables.
• Ensure production of high-quality tables, listings, and figures for Clinical Study Reports, regulatory submissions, publications, presentations, and internal decision-making.
• Partner with Biostatistics to align programming with Statistical Analysis Plans, study objectives, and regulatory expectations.
• Establish programming standards, validation methods, quality control procedures, and reusable tools; manage programming resources, timelines, priorities, and vendor-supported work.
• Lead strategy, governance, implementation, and continuous improvement of Clinical Affairs technologies, including EDC/CDMS, CTMS, eTMF, AI-enabled solutions, and related platforms.
• Evaluate, select, and oversee clinical technology vendors and ensure solutions align with business needs, regulatory requirements, and Clinical Affairs objectives.
• Oversee system implementation, validation, integration, enhancements, and change control.
• Drive interoperability, process optimization, and technology adoption to improve efficiency, data quality, and decision-making across the study lifecycle.
• Partner with Information Technology, Quality, Regulatory Affairs, and vendors to evaluate, implement, validate, and optimize systems and AI-enabled solutions.
• Monitor industry trends and emerging technologies and recommend and implement solutions that strengthen Clinical Affairs capabilities.
• Serve as the primary Clinical Affairs liaison for Information Technology and oversee Clinical Systems vendors’ performance, compliance, and service delivery.
• Establish and maintain standards, procedures, and controls for Clinical Data Management, Statistical Programming, Clinical Affairs systems, and AI-enabled technologies.
• Ensure compliance with 21 CFR Part 11, Good Clinical Practice, data privacy requirements, internal quality standards, and other applicable regulations.
• Lead governance, validation, risk management, change-control, and audit-readiness activities for Clinical Affairs systems and AI-enabled technologies.
• Ensure data integrity, transparency, traceability, human oversight, and appropriate validation across systems, processes, and AI-enabled solutions.

Benefits

• Comprehensive training upon joining and continued development and training throughout the career.
• Bonus eligible.