Senior Clinical Data Manager: CRO Lead & Data Integrity

Katalyst CRO; Omaha (NE); On-site; USD 120,000 - 150,000; Full time

Job summary

Katalyst CRO seeks an experienced Data Manager to oversee CRO activities from database start-up to CSR/submission. You will coordinate with DM CROs, vendors and study teams to meet timelines and ensure data quality across eCRFs, edit checks and validation.

You will lead the development of key DM documents and systems, manage data cleaning, and ensure regulatory compliance, with strong collaboration across clinical operations and programming teams.

Qualifications

• Bachelor's degree in a science-related field and/or computer systems/IT background.
• At least 8 years data management experience in pharma/Biotech/CRO.
• Familiarity with CDISC/CDASH including the SDTM model.
• Familiarity with standard coding dictionaries (WHODD, MedDRA).
• Familiarity with Pinnacle 21.
• Experience with Trial Master File (paper or electronic).
• Experience with various EDC software (Medidata RAVE, Medrio, Oracle, Inform, Veeva CTMS, IXRS).
• Ability to multitask and prioritize; strong organizational and project management skills.
• Experience working with CROs and vendor oversight.
• Ability to interact with Clinical Ops, Medical, Regulatory, QA, Programming, Biostatistics.
• Working knowledge of Good Clinical Practices and regulatory terminology.

Responsibilities

• Oversee data management CRO activities from start-up to CSR/submission.
• Serve as primary contact with DM CROs, vendors, and internal teams.
• Develop study timelines with DM CROs and ensure deliverables.
• Oversee DB development including eCRF, edit checks, validation, UAT.
• Develop DM documents (CRFs, DMPs, edit checks) and ensure compliance.
• Oversee systems like ePRO, IVRS, Central Lab, Central ECG.
• Manage data cleaning and reconciliation with external databases.
• Review study SOWs, RPFS, budgets, and change orders.
• Ensure data quality in EDC and external data for lock/unlock.

Skills

Project management

Vendor oversight

Regulatory knowledge

Cross-functional collaboration

Education

Bachelor's degree in science or IT

Tools

Medidata RAVE

Medrio

Oracle

Inform

Veeva CTMS

IXRS

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

Katalyst CRO seeks an experienced Data Manager to oversee CRO activities from database start-up to CSR/submission. You will coordinate with DM CROs, vendors and study teams to meet timelines and ensure data quality across eCRFs, edit checks and validation.

You will lead the development of key DM documents and systems, manage data cleaning, and ensure regulatory compliance, with strong collaboration across clinical operations and programming teams.