Senior Clinical Data Management (IIT Portfolio)

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Monday-Friday

Great care starts with great people. (Like you.)

At HonorHealth, you’ll find something special. From humble beginnings in 1927 to one of Arizona’s largest nonprofit healthcare systems, our culture is built on warmth and neighborly kindness. Behind every smile is a highly skilled professional with deep expertise and an unwavering dedication to what matters most - caring for the health and well-being of people and communities across the greater Phoenix area.

Responsibilities:

JOB SUMMARY

This position provides comprehensive data management support for investigator-initiated trials (IITs) within Research Sponsor Management Office. This position is responsible for the design, development, and maintenance of case report forms (CRFs), data extraction and reporting, and ensuring data quality and integrity across all IITs. Will work closely with principal investigators, biostatisticians, and clinical teams to support study objectives and regulatory compliance.

ESSENTIAL FUNCTIONS

• Portfolio Oversight & Data Governance:

  Develop and maintain a centralized data infrastructure to support oversight of all IITs

  Ensure all studies have minimum required data fields to support regulatory compliance and safety monitoring

  Standardize data elements across trials (e.g., safety events, enrollment, endpoints)

  Support development of institutional dashboards for study status, safety, and compliance

• Data Development & Management:

  Design, build, and maintain electronic case report forms (eCRFs) in electronic data capture systems in accordance with protocol requirements and data standards

  Create and manage data collection instruments that align with study safety and efficacy objectives

  Ensure CRFs are mapped to safety endpoints and support downstream statistical analysis

  Revise and update CRFs as needed throughout the study lifecycle

• Data Extraction & Review Support:

  Extract data from CRFs to support ongoing study reviews, safety monitoring, and interim analyses

  Prepare data listings, summaries, and reports for investigator review

  Identify and resolve data discrepancies through query management

• Reporting & Submissions:

  Generate and maintain standardized reports across all IITs

  Support data submission requirements including safety reporting and regulatory filings

  Maintain accurate and audit-ready documentation of all data management activities

  Ensure data systems support DSMB reviews, safety reporting, and regulatory submissions

  Flag missing or incomplete data that could impact patient safety or regulatory compliance

• Collaboration & Coordination:

  Work closely with principal investigators and biostatistics to ensure data collection aligns with protocol objectives within regulatory parameters.

  Partner with biostatisticians to ensure data structure and format support planned analyses

  Collaborate with clinical and regulatory teams to maintain data quality and compliance

  Participate in study team meetings and contribute to data management planning

  Integrate data across clinical trials management systems (CTMS), electronic data capture, regulatory, pharmacy systems, etc. to ensure consistency between systems used for regulatory and operational tracking

• Systems & Quality:

  Serve as the primary point of contact for IIT EDC system administration and user support

  Develop and maintain data management plans, data dictionaries, and standard operating procedures

  Ensure compliance with applicable regulations including 21 CFR Part 11, ICH E6 Good Clinical Practice, and institutional policies

  Identify and escalate data-related compliance risks to leadership

EDUCATION

• Bachelors in a relevant field with significant data management training Required
• Masters in Epidemiology, Biostatistics, Health Informatics, or a closely related field with significant data management training Preferred

EXPERIENCE

• 5 years, of experience in clinical data management, preferably in an academic medical center or research institution Required
• 8 years, of experience in clinical data management, preferably in an academic medical center or research institution Preferred

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