Manager, Clinical Data and Systems

Hologic•San Diego, CA

1d•$124,200 - $206,800•Onsite

About The Position

The Manager, Clinical Data and Systems leads the Clinical Data Management and Statistical Programming functions within Clinical Affairs, providing strategic and operational leadership for acquiring, analyzing, and delivering high-quality clinical data and evidence to support global regulatory submissions. The role develops and leads high-performing teams while overseeing clinical data, statistical programming, Clinical Affairs technologies, and AI-enabled solutions throughout the clinical study lifecycle. In partnership with Clinical Affairs and cross-functional stakeholders, the Manager drives data quality, operational excellence, regulatory compliance, and adoption of innovative technologies that enhance the generation of high-quality clinical evidence. This is a full-time, onsite position in San Diego, California, requiring onsite presence five days per week. The role oversees Clinical Data Management activities from study startup through database lock and close; Statistical Programming outputs and standards; Clinical Affairs technology strategy and governance, including EDC/CDMS, CTMS, eTMF, and AI-enabled solutions; and compliance, validation, risk management, and audit readiness.

Requirements

Bachelor's degree in Life Sciences, Computer Science, Statistics, Data Science, Information Systems, or a related field with at least 8 years of relevant experience; or a master's degree with at least 6 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, including translating 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 artificial intelligence and machine learning concepts and their application in clinical data management and clinical trial systems.
For successful performance, the individual must be able to fulfill each essential responsibility.

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, in vitro diagnostics, medical devices, or another 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, fostering accountability, collaboration, and continuous improvement.
Establish team goals, performance metrics, operating processes, and resource plans.
Manage budgets, priorities, and resources across multiple 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 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 from study startup through database lock and close, delivering accurate, complete, and reliable clinical data.
Direct Data Management Plans, edit-check specifications, reconciliation, 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.
Establish data standards, quality controls, and processes that support data integrity, traceability, and inspection readiness.
Provide technical leadership on clinical data management methods, technologies, and industry best practices.
Lead Statistical Programming and ensure timely, accurate, and compliant programming outputs.
Oversee development, validation, review, and quality control of datasets, programming specifications, analyses, and study deliverables.
Ensure production of tables, listings, and figures supporting Clinical Study Reports, regulatory submissions, scientific publications, presentations, and internal decisions.
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 activities across clinical programs.
Lead strategy, governance, implementation, and continuous improvement of Clinical Affairs technologies, including EDC/CDMS, CTMS, eTMF, AI-enabled solutions, and related digital platforms.
Evaluate, select, and oversee clinical technology vendors to ensure solutions meet business needs, regulatory requirements, and Clinical Affairs objectives.
Oversee clinical system implementation, validation, integration, enhancements, and change control.
Drive system interoperability, process optimization, and technology adoption across the clinical study lifecycle.
Partner with Information Technology, Quality, Regulatory Affairs, and external vendors to evaluate, implement, validate, and optimize systems and AI-enabled solutions.
Monitor industry trends and emerging technologies and recommend or implement solutions that strengthen Clinical Affairs.
Serve as the primary Clinical Affairs liaison for Information Technology and oversee Clinical Systems vendor performance, compliance, and service delivery.
Establish 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, applicable data privacy requirements, internal quality standards, and other relevant regulations.
Lead governance, validation, risk management, change control, and audit-readiness activities for Clinical Affairs systems and AI-enabled technologies.
Maintain data integrity, transparency, traceability, human oversight, and appropriate validation across systems, processes, and AI-enabled solutions.
Perform other function-related activities as reasonably required by business needs.