Senior Clinical Data Manager

Job Summary

A company is looking for a Senior Clinical Data Manager to lead and contribute to data management activities in clinical drug development.

Key Responsibilities

• Lead data management activities and oversee database build, including eCRF content and user acceptance testing
• Monitor data collection and cleaning by vendors, ensuring adherence to study metrics and data reviews
• Collaborate with internal and external partners to establish data review plans and support database lock activities

Required Qualifications

• BS/BA in a scientific discipline
• At least 5 years of experience in a pharmaceutical/biologics/biotechnology company
• Experience in clinical drug development through Phase 3 in an outsourced CRO model
• Expert knowledge of eClinical processes and data management systems
• Understanding of regulations and industry standards such as CDISC, SDTM, and CDASH