Senior Clinical Data Manager - Lead CDM & Data Quality

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

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.