Job Description

• 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.

• Bachelor's degree in science or related field or equivalent defined as a minimum of 6 years related, combined experience in employment, education, knowledge, and skills that will enable the incumbent to proficiently perform the duties of the role is required.
• Minimum 6 years industry experience in clinical data management if bachelor's degree; Minimum 4 years industry experience in clinical data management if master's degree.
• Leadership experience gained leading projects or teams.
• Strong communication and project management skills.

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