Lead Clinical Data Manager: Drive Data Integrity & Delivery

Katalyst CRO; Charlotte (NC); On-site; USD 95,000 - 130,000; Full time

Job summary

Katalyst CRO in Charlotte, NC seeks a data management lead to drive the DM lifecycle from study start-up through close-out. You will tailor DM documents (DMPs, CRFs, edit checks, data flow plans) using templates while applying critical thinking and collaboration.

Responsibilities include data cleaning, vendor management, SAS/R programming, and CDISC/GCP compliance, with cross-functional coordination among biostatistics, medical monitors, and data programmers.

Qualifications

• BA or BS and a minimum of 4 years of relevant experience.
• Technologically savvy; quickly picks-up new information, standards, regulations, tools, methods or software.
• Experience working within a Clinical EDC system (e.g., Medidata Rave, Veeva EDC).
• Experience with managing Lab Data, such as PK, PD, and Biomarkers.
• Detail-oriented; performs quality and accurate work.
• Knowledgeable in GCP standards, CDISC standards (CDASH, SDTM, ADaM), FDA and ICH guidelines, and GCDMP.

Responsibilities

• Leads all DM lifecycle activities, from study start-up, maintenance, database lock and close-out.
• Independently develop DM documents including DMPs, CRFs, CRF Completion Guidelines, Edit Checks, UAT specs, centralized monitoring plans, data flow and integrity plans, blinding plans, and data review plans.
• Independently lead data cleaning activities and gather cross-functional input for data review plans.
• Manage data deliverables processes and database locks with high quality and efficiency.
• Foster collaboration with study team representatives across functions.
• DM Project Management to ensure deliverables are met on time.
• Vendor/CRO management and involvement in vendor selection.
• Medical coding as needed and coordination with CROs and Medical Monitors.
• Run SAS and/or R programs, review logs, troubleshoot, and generate outputs.
• Evaluate CDM processes and participate in new process development.
• Develop DM-specific SOPs and oversee CRO data management activities.

Skills

Data management

SAS programming

R programming

Project management

Attention to detail

Cross-functional collaboration

GCDMP knowledge

Education

Bachelor's degree

Tools

Medidata Rave

Veeva EDC

SAS

R

Job description

Katalyst CRO in Charlotte, NC seeks a data management lead to drive the DM lifecycle from study start-up through close-out. You will tailor DM documents (DMPs, CRFs, edit checks, data flow plans) using templates while applying critical thinking and collaboration.

Responsibilities include data cleaning, vendor management, SAS/R programming, and CDISC/GCP compliance, with cross-functional coordination among biostatistics, medical monitors, and data programmers.