The Role
Lead clinical data management for investigator-initiated trials: design and maintain eCRFs/EDC systems, ensure data quality and regulatory compliance (21 CFR Part 11, ICH E6), extract and report data for safety/DSMB reviews, standardize data elements across trials, and coordinate with investigators, biostatistics, clinical, and regulatory teams.
Summary Generated by Built In
Primary City/State:
Shea Medical Office Building - 10290 N 92nd St Scottsdale, AZ 85258Category:
Research OperationsShift:
DayDepartment:
HRI-Translational ResearchMonday-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
LICENSE AND CERTIFICATIONS
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Skills Required
- Bachelor's degree in a relevant field with significant data management training
- Master's in Epidemiology, Biostatistics, Health Informatics, or closely related field with data management training
- 5 years of experience in clinical data management (preferably at an academic medical center or research institution)
- Experience designing, building, and maintaining electronic case report forms (eCRFs) and electronic data capture (EDC) system administration
- Knowledge of regulatory requirements including 21 CFR Part 11 and ICH E6 Good Clinical Practice
- Experience with data extraction, query management, preparing data listings/summaries, and supporting DSMB and safety reporting
- Experience developing data management plans, data dictionaries, standard operating procedures, and data governance for trial portfolios
- Experience integrating data across CTMS, EDC, regulatory, and pharmacy systems
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The Company
What We Do
This practice is a dedicated team of electrophysiologists, physician assistants, nurses and technicians, who as a group, are committed to treating and caring for patients experiencing problems with their heart's rhythm and electrical signaling.
