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Sr. Clinical Data Manager
Job in
Phoenix, Maricopa County, Arizona, 85003, USA
Listed on 2026-09-25
Listing for:
Katalyst CRO
Full Time
position Listed on 2026-09-25
Job specializations:
-
Healthcare
Healthcare Management
Job Description & How to Apply Below
- Provide leadership, strategic planning, direction and implementation of clinical systems for data collection which may include vendor selection, budgeting, resource planning, vendor oversight, EDC build and study timelines, etc.
- Perform or provide oversight to staff for all CDM activities from study startup to archival: design CRFs/eCRFs, create Data Validation Specifications, Data Management Plans, eCRF Completion Guidelines, and Data Review Plans, code terms in MedDRA and WHODrug; and complete data base lock, archival, and closeout activities
- Develop and manage standard operation procedures (SOP and CLPs) for clinical investigation data management;
Data Management Plans (DMP), eCRFs, user acceptance testing (UAT) plans and scripts; EDC build and associated edit checks - Provide study level metrics/reports and external data reconciliation processes relating to CRF review, query status, data entry, monitoring status, management of independent review vendors, and any other relevant matters; translate metrics into performance assessment and opportunities
- Collaborate with cross-functional team and management to implement and govern CDM processes and standards to meet all applicable quality requirements and regulations, manage and oversee all phases of data management activities
- Provide program/study level oversight and expertise for CDM activities for multiple studies
- Review clinical data on an ongoing basis to ensure consistency, integrity and accuracy; assess and identify key data issues, trends or patterns that may pose overall study compliance and/or data quality concerns
- Establish external data reconciliation processes; develop CDM processes for management and determination of adjudication for independent review of video-endoscopies, CT scans
- Evaluate and manage CROs and external technology vendors to meet company's goals and CDM standards
- Build and drive positive relationships and teamwork within the clinical team and partnering sites with professional demeanor
- Make decisions and chart course through careful evaluation of risks and benefits with limited information in conjunction with leadership; serve as the interdepartmental subject matter expert for the CDM area
- Evaluate and manage CROs and external technology vendors to meet company's goals and clinical data management quality standards on an ongoing basis
- Assist with routine quality audits as applicable
- Provide leadership, strategic planning, direction and implementation of clinical systems for data collection which may include vendor selection, budgeting, resource planning, vendor oversight, EDC build and study timelines, etc.
- Perform or provide oversight to staff for all CDM activities from study startup to archival: design CRFs/eCRFs, create Data Validation Specifications, Data Management Plans, eCRF Completion Guidelines, and Data Review Plans, code terms in MedDRA and WHODrug; and complete data base lock, archival, and closeout activities
- Develop and manage standard operation procedures (SOP and CLPs) for clinical investigation data management;
Data Management Plans (DMP), eCRFs, user acceptance testing (UAT) plans and scripts; EDC build and associated edit checks - Provide study level metrics/reports and external data reconciliation processes relating to CRF review, query status, data entry, monitoring status, management of independent review vendors, and any other relevant matters; translate metrics into performance assessment and opportunities
- Collaborate with cross-functional team and management to implement and govern CDM processes and standards to meet all applicable quality requirements and regulations, manage and oversee all phases of data management activities
- Provide program/study level oversight and expertise for CDM activities for multiple studies
- Review clinical data on an ongoing basis to ensure consistency, integrity and accuracy; assess and identify key data issues, trends or patterns that may pose overall study compliance and/or data quality concerns
- Establish external data reconciliation processes; develop CDM processes for management and determination of adjudication for independent review of video-endoscopies, CT scans
- Evaluate and manage CROs and external technology vendors to meet company's goals and CDM standards
- Build and drive positive relationships and teamwork within the clinical team and partnering sites with professional demeanor
- Make decisions and chart course through careful evaluation of risks and benefits with limited information…
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