Experience

Firma Clinical Research

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Sr. Data Manager, Data Management

  • Sep 2011 - Present

  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. Show less

• Sr. Data Manager, Data Management

  • Sep 2011 - Present

  • 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. Show less