Senior Clinical Data Manager — EDC/CDM Strategy Lead

Katalyst CRO; Boulder (CO); On-site; USD 95,000 - 130,000; Full time

Job summary

Katalyst CRO is seeking a senior clinician data management leader to guide data collection strategy, oversight of CDM activities, and vendor relationships across studies. The role emphasizes regulatory alignment and data integrity throughout the program lifecycle.

You will design CRFs/eCRFs, develop DMPs and SOPs, monitor study metrics, and drive cross-functional collaboration to meet FDA-related timelines for device and medical product programs.

Qualifications

• Bachelor's degree in a scientific field is required or preferred.
• 9+ years of CDM experience across all study phases with leadership.
• GCP/ICH/FDA regulatory knowledge and device/CDM familiarity.

Responsibilities

• Provide leadership, strategic planning, direction and implementation of clinical systems for data collection.
• Oversee CDM activities from startup to archival; eCRF/CRF design and data validation.
• Develop SOPs and DMPs for data management and UAT plans.
• Generate study metrics, support data reconciliation and trend analysis.
• Collaborate to govern CDM processes and ensure quality/regulatory compliance.
• Manage CROs and external vendors; advise on adjudication for diagnostics.
• Review data for consistency and accuracy; manage data issues and timelines.
• Support QA audits and continuous improvement of CDM programs.

Skills

CDM leadership

Project management

Regulatory knowledge

CDASH/SDTM standards

Vendor management

Communication skills

Clinical systems

Attention to detail

Independent work

Education

Bachelor's Degree in science

RN or advanced degree preferred

Job description

Katalyst CRO is seeking a senior clinician data management leader to guide data collection strategy, oversight of CDM activities, and vendor relationships across studies. The role emphasizes regulatory alignment and data integrity throughout the program lifecycle.

You will design CRFs/eCRFs, develop DMPs and SOPs, monitor study metrics, and drive cross-functional collaboration to meet FDA-related timelines for device and medical product programs.