Senior Clinical Data Manager

Job Summary

Serving as the data management lead on assigned studies, the contract Senior Clinical Data Manager will oversee database setup, author study-level documents, and manage CRO and vendor activities while working remotely.

Key responsibilities

• Lead data management efforts on studies, providing input on timelines and deliverables
• Author and review data management documents, including Data Management Plans and coding conventions
• Manage CRO and vendor data management activities, ensuring effective collaboration and oversight

Required qualifications

• Bachelor's degree in life sciences, health sciences, mathematics, computer science, or a related field
• Minimum of 5 years of data management experience in the pharmaceutical or biotechnology industry
• Oncology experience strongly preferred
• Working knowledge of ICH, FDA, and GCP regulations and guidelines
• Experience with EDC systems and familiarity with CDISC, SDTM, and CDASH standards