Senior Clinical Data Manager - Lead CDM & Data Systems

Katalyst CRO; Boulder (CO); On-site; USD 120,000 - 190,000; Full time

Job summary

Katalyst CRO in Boulder, CO seeks a data-driven CDM leader to drive clinical data management across studies for medical devices. You will design CRFs/eCRFs, oversee data validation, DMPs, edit checks, and SOPs, ensure QC and regulatory alignment, and manage CROs and external vendors.

Responsibilities include study-level oversight, data review, metrics reporting, and guiding a cross-functional team through study startup to archival, with emphasis on quality, timeliness, and FDA-compliant

Qualifications

• Bachelor's Degree in scientific discipline (RN or advanced degree preferred).
• 9 years' industry experience in CDM across all study phases and activities, including leadership roles.
• Thorough knowledge of CDM standards for medical devices (Class III PMA devices preferred).
• Expertise in development, validation, and management of clinical study databases (CRF design, database development, testing, discrepancy mgmt, data quality review).
• Working knowledge of GCP, ICH and FDA guidance for clinical trials.
• Experience implementing, validating, and administrating other clinical systems for data collection (e.g., eSource, IVRS, IWRS, core lab portals).
• Demonstrated ability to manage complex projects with tight timelines.

Responsibilities

• Provide leadership, strategic planning, direction and implementation of clinical systems for data collection (vendor selection, budgeting, resource planning, vendor oversight, EDC build, study timelines).
• Perform or oversee staff for CDM activities from startup to archival: CRFs/eCRFs, Data Validation Specs, DMPs, eCRF guidelines, Data Review Plans; code terms in MedDRA and WHO Drug; complete database lock and closeout.
• Develop and manage SOPs/CLPs for clinical investigation data management; DMPs, eCRFs, UAT plans and scripts; EDC build and edit checks.
• Provide study-level metrics/reports and external data reconciliation; translate metrics into performance assessment and opportunities.
• Collaborate with cross-functional teams to govern CDM processes to meet quality requirements and regulations; oversee all phases of data management.
• Provide program/study level oversight for CDM activities across multiple studies.
• Review clinical data to ensure consistency, integrity and accuracy; identify data quality concerns and trends.
• Establish external data reconciliation processes; adjudication for independent review of video-endoscopies and CT scans.
• Evaluate and manage CROs and external technology vendors to meet company goals and CDM standards.
• Build and drive positive relationships within the clinical team and partnering sites.
• Make decisions with limited information in conjunction with leadership; serve as interdepartmental subject matter expert for CDM.
• Assist with routine quality audits as applicable.

Skills

CDM leadership

Data management

Regulatory compliance

Vendor management

Education

Bachelor's Degree in scientific discipline

Advanced degree preferred

Tools

MedDRA coding

WHO Drug dictionary

Job description

Katalyst CRO in Boulder, CO seeks a data-driven CDM leader to drive clinical data management across studies for medical devices. You will design CRFs/eCRFs, oversee data validation, DMPs, edit checks, and SOPs, ensure QC and regulatory alignment, and manage CROs and external vendors.

Responsibilities include study-level oversight, data review, metrics reporting, and guiding a cross-functional team through study startup to archival, with emphasis on quality, timeliness, and FDA-compliant