Lead Clinical Data Manager for Global CRO Oncology Trials

Tempus AI; Illinois; On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Benefits package

Job summary

Tempus AI is seeking a Lead Clinical Data Manager to lead data management activities across global studies in a CRO setting. The role collaborates with cross-functional teams to ensure quality data and timely deliverables throughout all clinical trial phases, with emphasis on oncology and early-phase experience.

The ideal candidate has extensive EDC expertise (Medidata Rave preferred) and strong regulatory knowledge, enabling effective data governance and inspection readiness within Tempus AI's

Qualifications

• BS/BA in scientific discipline; MS preferred; 8+ years CRO/pharma/biotech experience
• Study/vendor oversight experience
• Experience with global studies using outsourced CRO model
• Expert knowledge of Data Management processes and EDC systems
• Knowledge of CDISC SDTM and CDASH standards
• ICH GCP understanding and regulatory requirements for clinical data systems including 21 CFR Part 11
• Strong organizational skills and ability to work independently and in a team
• Proficient in Microsoft Word and Excel

Responsibilities

• Lead eCRF content development by coordinating cross-functional reviews
• Oversee database build activities and vendor testing (UAT)
• Monitor data collection, coding, and cleaning by vendors; track study metrics
• Oversee database lock activities and archiving of study data
• Collaborate with Biostatistics, Statistical Programming, Clinical Operations, Medical, QA, Drug Safety and Pharmacovigilance; CROs and labs
• Establish cross-functional data review plans and coordinate data transfers
• Review CRO data management plans, CRF guidelines, edit checks, and data transfer specs
• Communicate requirements, strategy, timelines and deliverables in cross-functional and vendor meetings
• Draft/review timelines to align with company goals and milestones
• Support GCP inspection readiness

Skills

Data management

Cross-functional collaboration

Regulatory knowledge

GxP / GCP awareness

Word & Excel proficiency

Education

BS/BA in scientific discipline

MS or equivalent preferred

Tools

Medidata Rave EDC

Job description

Tempus AI is seeking a Lead Clinical Data Manager to lead data management activities across global studies in a CRO setting. The role collaborates with cross-functional teams to ensure quality data and timely deliverables throughout all clinical trial phases, with emphasis on oncology and early-phase experience.

The ideal candidate has extensive EDC expertise (Medidata Rave preferred) and strong regulatory knowledge, enabling effective data governance and inspection readiness within Tempus AI's