eCOA Data Specialist

Job Description

: Provide basic and some comprehensive data management expertise to the eCOA Data Management (DM) team to deliver efficient, quality data management products that meet customer needs. May also undertake eCOA Data Management activities under the supervision of the Data Team Lead (DTL)/ Sr DTL, or Functional Manager. Essential Functions: - Undertake eCOA Data Management activities for assigned studies, with/without supervision. - May serve in the role of back-up to a DTL. - Perform testing of programming and data transfers. - Understand and comply with core operating procedures and working instructions. - Meet objectives as assigned and develop and maintain good communications and working relationships within eCOA DM team. - Database Design and Maintenance: Create and maintain clinical databases to ensure they are efficient and meet the needs of the clinical trials. - Data Querying and Reporting: Manage queries and generate reports for analysis. - Data Validation: Analyze and resolve discrepancies from Recon/CTMS inquiries. - Study Close-out: Execute end-to-end study close-out activities, include Archival. - Identify opportunities to automate and improve data collection and management processes. Qualifications: - Bachelor s degree in pharmacy or equivalent preferred. - 3-6 years of direct data management experience, preferably a minimum of 1 year as a CDM project lead. - Good to have experience in electronic Clinical Outcome Assessment (eCOA) or Decentralized Clinical Trials (DCT). - Advanced proficiency in English, both spoken and written. - Advanced skills in computer applications like Microsoft Excel, Word, Outlook, etc. - Advanced understanding of the drug development lifecycle and overall clinical research process.