Sr. Data Associate, Data Management Science

Role Summary

Sr. Data Associate, Data Management Science. The Sr. Data Associate supports the Clinical Program and acts as the GDS DMS Study Lead in the execution of assigned data management tasks, contributing to the delivery of complete, correct, and consistently fit-for-purpose study datasets for statistical analysis.

Responsibilities

• Draft Case Report Form (eCRF) in a concise, self-explanatory, and user-friendly format; collaborate with study team to ensure eCRF completion guidelines/instructions are accurate
• Draft Data Management Plan outlining key Data Management activities and deliverables
• Collaborate with Clinical Programming and Data Quality Science and facilitate the completion of the Data Validation Plan
• Conduct ongoing/periodic data validation activities, including reviews of data listings, discrepancies, and follow-up on queries with investigators
• Draft data transfer specifications
• Conduct SAE reconciliation activities
• Maintain data transfer calendar requirements
• Post listings/reports/profiles to study file locations
• Reconcile external data, including drafting data transfer specifications and header data
• Maintain and track timeline, discrepancies, query resolution, and deliverable status
• Track data flows and data review status
• Maintain Trial Master File (eTMF) updates for all data management deliverables
• Participate in initiatives to expand Global Data Science and Data Management Science capabilities; build best practices in processes, tools, templates, or guidance for the subject area

Qualifications

• MA degree preferred, or BA/BS degree with a focus in statistics, computer science, life science, or related discipline
• 2+ years of experience in clinical development, including technical experience within and outside of Data Management; 5+ years with BS

Skills

• Decision Making, Critical Thinking and Problem Solving; ability to gather data from multiple sources to develop holistic understanding and solutions
• Influence, Cross-Functional Collaboration and Organizational Awareness
• Agility and Proactivity; resourcefulness to obtain information needed for timely closeout of tasks
• Leadership; clear communication of objectives and understanding of study team roles
• Communication; prompt, clear, organized responses to stakeholders
• Strategic Thinking and Planning; focus on performance measurement
• Operations; basic understanding of how programming supports study execution; experience with clinical data programming
• General data management science skills; development of comprehensive data validation plans; familiarity with drug development phases and medical coding terms

Education

• MA degree preferred, or BA/BS with relevant focus

Additional Requirements

• Travel: Not explicitly required
• Physical demands: Not applicable beyond standard office work; no specific essential physical demands listed