Principal Data Manager

Responsibilities :

• Lead the data management activities from study start-up through the entire data cleaning process until database lock to support the clinical studies.
• Oversee all project related data management activities and manage project resources and timelines to ensure deliverables and targets are met.
• Create data management plan, edit check document, and Case Report Form (CRF) completion guidelines.
• Perform user acceptance testing (UAT) for Electronic Data Capture (EDC) systems.
• Clean database by generating, reviewing, and closing query resolutions through daily Case Report Form review.
• Help site support to answer study-related questions and perform EDC training, as needed.
• Communicate with Clinical Research Associate (CRA), sponsor, and third-party vendors (such as central laboratory) to discuss study related functions.
• Perform AE / SAE (Adverse Event / Serious Adverse Event) and third-party data (such as Pharmacokinetic lab and safety lab) reconciliation.
• Communicate with other internal departments to maintain and track project timelines.
• Perform database audit, as needed, lock and clinical data archive.
• Perform quality control on various types of tasks, such as review edit check listings and manage DM documentation and study reports.

Requirements :