Senior Clinical Data Management (IIT Portfolio)

Shea Medical Office Building - 10290 N 92nd St, Scottsdale, AZ 85258 | Monday-Friday day shift

About the role

This position provides comprehensive data management support for investigator-initiated trials (IITs) within the Research Sponsor Management Office. Responsibilities include designing, developing, and maintaining case report forms (CRFs), data extraction and reporting, and ensuring data quality and integrity across all IITs. The role involves close collaboration with principal investigators, biostatisticians, and clinical teams to support study objectives and regulatory compliance.

Responsibilities

• 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 biostatisticians 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

Qualifications

• Education:
  • Bachelor’s in a relevant field with significant data management training (Required)
  • Master’s 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)