Sr. Clinical Data Manager

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

• 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 WHO Drug; 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 WHO Drug; 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 WHO Drug 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