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Clinical Data Manager- Remote
Remote- Nationwide, NC 99999 United States
Must be hands on Data Manager
Provide clinical data management support to Clinical Operations and/or study project team, the Clinical Data Management team and Biostatistics team.
Develop Data Management Plan (DMP), maintain DMP throughout lifecycle of study project and ensures DMP is followed according to study design and requirements.
Build and develop database (DB) to adhere to clinical trial data specifications, including electronic Case Report Form (eCRF) design, user requirements, edit rules/checks, query logic and data validations.
Coordinate User Acceptance Testing (UAT) of Electronic Data Capture (EDC) build and validation documents, included but not limited to: test scripts, execution logs for UAT, edit checks, data listings, data reconciliation and/or coding and UAT summary report.
Develop CRF Completion Guidelines (CCG), maintain CCGs throughout lifecycle of study project and ensure CCGs adequately equip sites with instruction on how to enter data.
Bachelor's degree in health or science or equivalent practical experience.
5 years of data management and/or related work experience in a medical device or pharmaceutical industry/company.
Experience with Good Clinical Practices, Good Manufacturing Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.
Experience with Clinical database applications such as EDC and CTMS.
Experience with working on Phase I- IV study trials within the medical device and/or pharmaceutical industry.
Experience with MedDRA/Adverse Event (AE) Coding.
Applicable knowledge working with other clinical databases/EDC systems such as eClinicalOS, SAS, Medrio.
North Carolina Biotechnology Center