Lead Clinical Data Manager: Drive DM Lifecycle & Data Quality

Katalyst CRO; Dallas (TX); On-site; USD 95,000 - 135,000; Full time

Job summary

Katalyst CRO is seeking a skilled Data Management lead to own the full DM lifecycle for clinical trials. You will develop essential documents, coordinate data cleaning activities, and ensure timely and accurate data deliverables in collaboration with cross-functional teams to support study success.

The role requires strong knowledge of CDISC standards, GCP/ICH guidelines, and experience with DM systems such as Medidata Rave and Veeva EDC. Oncology experience is a plus.

Qualifications

• BA or BS degree with 4+ years of relevant clinical data management experience.
• Strong knowledge of GCP, CDISC (CDASH/SDTM/ADaM), FDA/ICH guidelines.
• Experience with data management lifecycles and data cleaning.
• Experience coordinating with CROs/vendors and internal study teams.

Responsibilities

• Lead all DM lifecycle activities from study start-up to close-out.
• Develop DM documents (DMPs, CRFs, CRF Completion Guidelines, edit checks, UAT specs).
• Lead data cleaning activities and design data review plans with cross-functional input.
• Manage data deliverables and database locks with high quality and efficiency.
• Foster collaboration with study team members (Biostatisticians, PMs, CRAs, etc.).
• Coordinate vendor/CRO work and assist in vendor selection and audits.
• Perform medical coding and coordinate data review with CROs and Medical Monitors.
• Run SAS and R programs, review logs, troubleshoot issues, and generate outputs.

Skills

DM lifecycle knowledge

Interpersonal & communication

Project management

Regulatory knowledge (GCP/ICH/CDISC)

Documentation writing

Education

BA or BS degree

Tools

SAS programming

Medidata Rave

Veeva EDC

RTSM

eCOA/ePRO systems

Job description

Katalyst CRO is seeking a skilled Data Management lead to own the full DM lifecycle for clinical trials. You will develop essential documents, coordinate data cleaning activities, and ensure timely and accurate data deliverables in collaboration with cross-functional teams to support study success.

The role requires strong knowledge of CDISC standards, GCP/ICH guidelines, and experience with DM systems such as Medidata Rave and Veeva EDC. Oncology experience is a plus.