Manager, Clinical Data and Systems

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Manager, Clinical Data and Systems

San Diego, CA, United States

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Are you ready to help shape the future of diagnostic innovation? At Hologic, our Diagnostic Solutions R&D teams develop breakthrough technologies that advance women's health, infectious disease, and oncology care. Join us in transforming scientific discovery into impactful diagnostic solutions that improve patient outcomes worldwide.

The Manager, Clinical Data and Systems leads the Clinical Data Management and Statistical Programming functions within Clinical Affairs, providing strategic and operational leadership for the acquisition, analysis, and delivery of high-quality clinical data and evidence that support global regulatory submissions. This role develops and leads high-performing teams while overseeing clinical data, statistical programming, Clinical Affairs technologies, and AI-enabled solutions across the clinical study lifecycle. Partnering closely with Clinical Affairs and cross-functional stakeholders, the Manager drives data quality, operational excellence, regulatory compliance, and the adoption of innovative technologies that enhance Hologic's ability to generate high-quality clinical evidence.

We are looking for an experienced Manager, Clinical Data and Systems to join the team in San Diego, CA. This position requires full-time onsite presence five days per week.

Essential Duties and Responsibilities

The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.

Management and Leadership

• Provide strategic and operational leadership for the Clinical Data Management and Statistical Programming functions, ensuring alignment with Clinical Affairs and organizational objectives.
• Recruit, develop, and retain high-performing teams while fostering a culture of accountability, collaboration, and continuous improvement.
• Establish goals, performance metrics, operating processes, and resource plans that enable efficient, high-performing teams.
• 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 successful 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.

Clinical Data Management

• Lead Clinical Data Management activities from study startup through database lock and close, ensuring the delivery of accurate, complete, and reliable clinical data.
• Direct the development and execution of Data Management Plans, edit-check specifications, reconciliation activities, external data transfers, and related documentation.
• Oversee database design, eCRF development, query management, coding activities, data review, and database validation.
• Lead user acceptance testing, system validation, and database release activities to ensure compliant and fit-for-purpose clinical databases.
• Establish and maintain data standards, quality controls, and operational processes that promote data integrity, traceability, and inspection readiness.
• Provide technical leadership on clinical data management methodologies, technologies, and industry best practices.

Statistical Programming

• Lead the Statistical Programming function and ensure the delivery of timely, accurate, and compliant programming outputs.
• Oversee the development, validation, review, and quality control of datasets, programming specifications, analyses, and study deliverables.
• Ensure production of high-quality tables, listings, and figures (TLFs) supporting Clinical Study Reports, regulatory submissions, scientific publications, presentations, and internal decision-making.
• Partner with Biostatistics to align programming activities with Statistical Analysis Plans, study objectives, and regulatory expectations.
• Establish and maintain programming standards, validation methodologies, quality control procedures, and reusable programming tools that drive efficiency, consistency, and quality.
• Manage programming resources, timelines, priorities, and vendor-supported activities across multiple clinical programs.

Clinical Systems and Artificial Intelligence

• Lead the 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, ensuring solutions align with business needs, regulatory requirements, and Clinical Affairs objectives.
• Provide oversight of system implementation, validation, integration, enhancements, and change-control activities to support efficient, compliant, and scalable clinical trial execution.
• Drive system interoperability, process optimization, and technology adoption to improve operational efficiency, data quality, and decision-making across the clinical study lifecycle.
• Partner with Information Technology, Quality, Regulatory Affairs, and external vendors to evaluate, implement, validate, and optimize Clinical Affairs systems and AI-enabled solutions.
• Monitor industry trends and emerging technologies, recommending and implementing solutions that strengthen Clinical Affairs capabilities and organizational effectiveness.
• Serve as the primary Clinical Affairs liaison for Information Technology and maintain oversight of Clinical Systems vendors, including performance, compliance, and service delivery.

Compliance

• Establish and maintain standards, procedures, and controls governing Clinical Data Management, Statistical Programming, Clinical Affairs systems, and AI-enabled technologies.
• Ensure compliance with 21 CFR Part 11, Good Clinical Practice (GCP), applicable data privacy requirements, internal quality standards, and other relevant regulatory requirements.
• 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 practices are maintained across systems, processes, and AI-enabled solutions.

Qualifications

Education and Experience

• Bachelor's degree in Life Sciences, Computer Science, Statistics, Data Science, Information Systems, or a related field with 8+ years of relevant experience; Master's degree with 6+ years of relevant experience. Master's degree preferred.

• Minimum 2 years of experience managing professional associates.

• Experience in diagnostics, in vitro diagnostics, medical devices, or another regulated life-sciences environment is strongly preferred.

• Demonstrated experience leading and developing Clinical Data Management and/or Statistical Programming professionals is required; experience applying that leadership in clinical trials, in vitro diagnostics, medical devices, or another regulated life-sciences environment is preferred.

Skills

To perform this role successfully, an individual must be able to fulfill each essential responsibility. The qualifications below represent the knowledge, skills, and abilities required:

• 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 provide oversight of statistical programming deliverables.
• Working knowledge of artificial intelligence (AI) and machine learning (ML) concepts and their application within clinical data management and clinical trial systems.
• Experience leading the selection, implementation, validation, administration, or governance of clinical technology platforms (e.g., EDC/CDMS, CTMS, eTMF) is strongly preferred.
• Experience evaluating or applying AI-enabled tools to clinical data management, clinical systems, or clinical documentation, with an understanding of validation, data integrity, privacy, human oversight, and regulatory considerations.

The annualized base salary range for this hourly role is $124,200 to $206,800 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.

Why Hologic?

We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.

If you have the right skills and experience, apply today!

Agency and Third Party Recruiter Notice:

Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.

Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.

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