Clinical Data Manager

Job Summary

Managing study data management activities, the remote Clinical Data Manager II will oversee data cleaning efforts, facilitate cross-functional meetings, and ensure the delivery of EDC study deliverables over a six-month contract.

Key responsibilities

• Assist in writing and managing key documents such as Data Management Plans and edit check specifications
• Manage User Acceptance Testing (UAT) of clinical databases and oversee data cleaning efforts
• Represent Data Management in study team meetings, providing data status metrics and guidance on data-related issues

Required qualifications

• 2-5 years of relevant experience in Clinical Data Management within the Pharmaceutical/Medical Device/Biotechnology/CRO industry
• In-depth knowledge of FDA/ICH guidelines and data management practices
• Hands-on experience with Electronic Data Capture (EDC) systems and data review tools
• Experience in writing Data Management documentation such as DMP and edit check specifications
• BS or higher in biological science, nursing, or a health-related discipline preferred