Senior Clinical Data Manager - CDM Lead (Medical Devices)

Katalyst CRO; Irvine (CA); On-site; USD 170,000 - 210,000; Full time

Job summary

Katalyst CRO is seeking a senior Clinical Data Management leader to drive CDM strategy across multiple studies in the US. You will oversee data management plans, CRF design, data quality controls and vendor oversight, ensuring FDA/ICH compliance and timely data locks.

Responsibilities include building CDM SOPs, managing cross-functional teams, and delivering study metrics that inform decisions. Strong communication and project management skills are essential.

Qualifications

• Bachelor's degree required in scientific discipline.
• 9 years industry CDM experience including lead role for clinical development programs with medical devices.
• Thorough knowledge of CDM standards for medical devices (Class III PMA devices preferred).
• Expertise in CRF design, database life cycle and data quality review.
• Working knowledge of GCP, ICH and FDA guidance for clinical trials.

Responsibilities

• Provide leadership, strategic planning, direction and implementation of clinical systems for data collection.
• Oversight to staff for all CDM activities from startup to archival: CRF design, DMPs, UAT plans and scripts.
• Develop SOPs for clinical investigation data management and associated edit checks.
• Provide study level metrics and data reconciliation processes; translate metrics into performance assessment.
• Collaborate with cross-functional teams to implement and govern CDM processes and standards.
• Review clinical data continually to ensure consistency, integrity and accuracy; identify data quality concerns.

Skills

CDM leadership

MedDRA/WHO Drug coding

GCP/ICH/FDA knowledge

CDMS/EDC systems

Education

Bachelor's degree in scientific discipline

Tools

eSource systems

IVRS/IWRS

core lab portals

Job description

Katalyst CRO is seeking a senior Clinical Data Management leader to drive CDM strategy across multiple studies in the US. You will oversee data management plans, CRF design, data quality controls and vendor oversight, ensuring FDA/ICH compliance and timely data locks.

Responsibilities include building CDM SOPs, managing cross-functional teams, and delivering study metrics that inform decisions. Strong communication and project management skills are essential.