Clinical Data Manager: Lead DM Lifecycle & Data Quality

Katalyst CRO; Chicago (IL); On-site; USD 120,000 - 160,000; Full time

Job summary

Katalyst CRO is seeking an experienced Data Management Lead to own the data management lifecycle for complex clinical programs in a fast-paced environment. You will create and tailor DM documents, drive data cleaning plans, and ensure timely database locks while coordinating with cross-functional teams including biostatistics, programming, and clinical operations.

The role requires strong DM expertise (CDISC, GCP/ICH), EDC experience (Medidata Rave, Veeva), and hands-on SAS/R data programming to

Qualifications

• Requires a BA/BS with minimum 4 years’ relevant experience in DM.
• Proficient in CDISC SDTM/ADaM and GCP/ICH guidelines.
• Experience with EDC systems (Medidata Rave, Veeva).
• Strong data management problem solving and attention to detail.
• Experience leading DM deliverables and vendor oversight.
• Familiarity with RTSM and eCOA/ePRO is a plus.

Responsibilities

• Lead all data management lifecycle activities from study start-up to close-out.
• Develop DM documents (DMPs, CRFs, edit checks, data reviews).
• Coordinate data cleaning and cross-functional data review plans.
• Manage DM deliverables and database locks with high quality and efficiency.
• Collaborate with statisticians, programmers, monitors, and CRAs.
• Oversee vendor/CRO activities and assist in selecting vendors.
• Perform medical coding coordination as needed.
• Run SAS/R programs and inspect logs to support data listings.
• Contribute to DM SOP development and process improvements.

Skills

Data management leadership

CDISC standards (CDASH, SDTM, ADaM)

GCP/ICH guidelines

DM lifecycle knowledge (P1-P3)

SAS programming

eCOA/RTSM systems

Vendor/CRO management

Project management

Cross-functional collaboration

Communication skills

Education

BA/BS in Life Sciences, Health Informatics, or related field

Tools

Medidata Rave

Veeva EDC

SAS

Req/Study documentation templates

Job description

Katalyst CRO is seeking an experienced Data Management Lead to own the data management lifecycle for complex clinical programs in a fast-paced environment. You will create and tailor DM documents, drive data cleaning plans, and ensure timely database locks while coordinating with cross-functional teams including biostatistics, programming, and clinical operations.

The role requires strong DM expertise (CDISC, GCP/ICH), EDC experience (Medidata Rave, Veeva), and hands-on SAS/R data programming to