Sr. Clinical Data Manager

Katalyst CRO; Phoenix (AZ); On-site; USD 120,000 - 180,000; Full time

Job summary

Katalyst CRO in Phoenix, AZ is seeking a senior Clinical Data Management (CDM) leader to guide data collection systems and vendor oversight across multiple studies. You will design CRFs/eCRFs, Data Management Plans, and validation specs, ensuring high data quality and regulatory compliance.

Lead CDM activities from startup through archival and collaborate with cross-functional teams to meet project timelines.

Qualifications

• Bachelor's Degree in scientific discipline (RN or advanced degree preferred).
• 9 years' industry experience in CDM across all study phases; ≥5 years in lead role for clinical development programs with medical devices toward FDA filings/approvals.
• Thorough knowledge of CDM standards for medical devices (Class III PMA devices preferred).
• Expertise in development, validation, and management of the clinical study database throughout its life cycle (CRF design, database development/testing, discrepancy management, data quality review, database close and lock).
• Working knowledge of GCP, ICH and FDA guidance and regulations for clinical trials.
• Experience implementing/validating/administrating other clinical systems for data collection (eSource, IVRS, IWRS, core lab portals).
• Excellent verbal and written communication skills.

Responsibilities

• Provide leadership and strategic planning for clinical data management systems and vendor oversight.
• Oversee CDM activities from study startup to archival; design CRFs/eCRFs and Data Management Plans.
• Create Data Validation Specifications, eCRF Completion Guidelines, and Data Review Plans; ensure data quality.
• Generate study-level metrics and external data reconciliation processes; translate metrics into performance improvements.
• Collaborate with cross-functional teams to govern CDM processes and standards; oversee all phases of data management.
• Provide program-level CDM oversight for multiple studies.
• Review clinical data continually to ensure data integrity and identify key issues or trends.
• Establish external data reconciliation processes for adjudication of video-endoscopies and CT scans.
• Evaluate CROs and external vendors to meet CDM standards and company goals.

Skills

Leadership

Strategic planning

Cross-functional collaboration

Data quality

Regulatory compliance

Risk assessment

Communication

Education

Bachelor's degree in scientific discipline

RN or advanced degree preferred

Tools

EDC

SDTM/CDASH

Job description

• 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

Responsibilities

• 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

Requirements

• Bachelor's Degree in scientific discipline (RN or advanced degree preferred)
• 9 years' industry experience in CDM in all study phases and activities from startup to archival with at least 5 years in lead role for clinical development programs with medical devices leading toward FDA filing / approvals
• Thorough knowledge of the CDM standards for medical devices (Class III PMA devices preferred)
• Expertise in development, validation, and management of the clinical study database throughout its life cycle, from CRF design, database development and testing, discrepancy management, data quality review and database close and lock procedures, CDASH and SDTM data formats
• Working knowledge of the GCP, ICH and FDA guidance and regulations for clinical trials
• Working knowledge of the MedDRA and WHODrug dictionary coding terms Able to complete tasks independently, accurately and efficiently with attention to detail and in a timely manger
• Experience in implementing, validating, and administrating other clinical systems for data collection (e.g., eSource, IVRS, IWRS, core lab web-based portals)
• Demonstrated ability to manage complex projects with tight timelines and overcome project roadblocks
• Excellent verbal and written communication skills