Lead Clinical Data Manager — Oncology & Early-Phase

Tempus Compass, LLC; Illinois; Hybrid; USD 120,000 - 180,000; Full time

Job summary

Tempus Compass, LLC is seeking a Lead Clinical Data Manager to drive data management across clinical studies in a CRO environment. You will work with Biostatistics, Clinical Operations, and vendors to ensure data quality and regulatory compliance, particularly in oncology and early-phase trials.

The role requires extensive experience with eCRF development, data cleaning, and database locks, and offers the opportunity to shape a new data management department within a global setting.

Qualifications

• BS/BA in scientific discipline required, MS or equivalent preferred.
• 8+ years in CRO/pharma/biotech data management or related field.
• Experience with global studies and outsourced CRO models.
• Expert knowledge of data management processes and EDC design/build.
• Familiarity with CDISC SDTM and CDASH, ICH GCP, 21 CFR Part 11.

Responsibilities

• Lead data management activities for clinical studies across phases.
• Oversee eCRF development and cross-functional reviews.
• Coordinate data cuts/transfers and data reviews with vendors.
• Review CRO data management plans, CRF guidelines, and transfer specs.
• Support GCP inspection readiness and regulatory compliance.

Skills

Data management

GCP

Regulatory compliance

Vendor management

Cross-functional collaboration

CDISC SDTM/CDASH

Team leadership

Education

Bachelor's degree in scientific discipline

MS or equivalent preferred

Tools

Medidata Rave EDC

EDC data management systems

Job description

Tempus Compass, LLC is seeking a Lead Clinical Data Manager to drive data management across clinical studies in a CRO environment. You will work with Biostatistics, Clinical Operations, and vendors to ensure data quality and regulatory compliance, particularly in oncology and early-phase trials.

The role requires extensive experience with eCRF development, data cleaning, and database locks, and offers the opportunity to shape a new data management department within a global setting.