Lead Clinical Data Manager – Global Trials & Oncology

Tempus AI; United States; À distance; USD 120 000 - 180 000; Plein temps

Avantages offerts par ce poste

Full benefits package

Incentive compensation

Résumé du poste

Tempus AI is seeking a Lead Clinical Data Manager to lead data management activities across global studies in oncology and early-phase programs. You will partner with cross-functional teams and CROs to ensure high-quality, compliant data for safety and efficacy analyses.

The role requires extensive experience with CDISC standards, Medidata Rave, and GCP regulatory knowledge, and a proven ability to build or lead a data management function within a CRO or sponsor environment.

Qualifications

• BS/BA in scientific discipline; MS preferred; 8+ years CRO/pharma/biologics experience.
• Study/vendor oversight experience.
• Experience with global studies using outsourced CRO model.
• Expert knowledge of Data Management processes and EDC systems.
• CDISC SDTM/CDASH knowledge.
• ICH GCP familiarity and 21 CFR Part 11 regulatory understanding.
• Strong organization and time management; ability to work independently.
• MS Word and Excel proficiency.

Responsabilités

• Lead data management activities for clinical studies and reviews of eCRF content.
• Oversee database builds, edit checks, and user acceptance testing.
• Monitor data collection, coding, cleaning, and study metrics.
• Coordinate data reviews with cross-functional teams and external vendors.
• Ensure data management plans and transfer specs are followed.
• Represent data management in cross-functional meetings and vendor communications.
• Support timelines and deliverables; participate in protocol/amendments reviews.
• Support GCP inspection readiness.
• Align with Tempus Compass values.
• Travel as needed.

Connaissances

Data Management

Vendor Oversight

Global Studies

EDC System Design

CDISC SDTM/CDASH

Formation

BS/BA in scientific discipline

MS preferred

8+ years CRO/pharma/biologics experience

Outils

Medidata Rave EDC

EDC systems

Microsoft Word/Excel

Description du poste

Tempus AI is seeking a Lead Clinical Data Manager to lead data management activities across global studies in oncology and early-phase programs. You will partner with cross-functional teams and CROs to ensure high-quality, compliant data for safety and efficacy analyses.

The role requires extensive experience with CDISC standards, Medidata Rave, and GCP regulatory knowledge, and a proven ability to build or lead a data management function within a CRO or sponsor environment.