Lead Clinical Data Manager – Oncology & Global Trials

Tempus; Chicago (IL); On-site; USD 130,000 - 180,000; Full time

Job summary

Tempus seeks a Lead Clinical Data Manager to drive data management for clinical studies across development stages and to lead cross-functional data initiatives. You will oversee eCRF content, database build, edit checks, and data cleaning with vendors, ensuring data quality and regulatory compliance.

The role requires expertise in data management, EDC systems like Medidata Rave, and CDISC standards, with experience in CRO settings and oncology/early-phase trials.

Qualifications

• BS/BA in scientific discipline; MS preferred.
• Experience with CRO/pharmaceutical/biologics/biotechnology environments.
• Study/vendor oversight experience.
• Global studies experience with outsourced CRO model.
• Expert knowledge of Data Management processes and EDC systems design/build.
• CDISC SDTM/CDASH knowledge.
• ICH GCP and 21 CFR Part 11 familiarity.

Responsibilities

• Lead data management activities for clinical studies across development stages.
• Oversee eCRF development and cross-functional reviews.
• Review CRF content, edit checks, and data transfer specs.
• Coordinate data cuts/transfers and data reviews with internal/external partners.
• Ensure database lock readiness and data archiving.
• Support GCP inspections and regulatory compliance.

Skills

Data management

GCP knowledge

EDC systems

Vendor oversight

Cross-functional collaboration

Communication skills

Project management

Global studies experience

Regulatory knowledge

Independent work

Education

BS/BA in scientific discipline

MS preferred

Tools

Medidata Rave EDC

MS Word

Excel

Job description

Tempus seeks a Lead Clinical Data Manager to drive data management for clinical studies across development stages and to lead cross-functional data initiatives. You will oversee eCRF content, database build, edit checks, and data cleaning with vendors, ensuring data quality and regulatory compliance.

The role requires expertise in data management, EDC systems like Medidata Rave, and CDISC standards, with experience in CRO settings and oncology/early-phase trials.