This list contains only the countries for which job offers have been published in the selected language (e.g., in the French version, only job offers written in French are displayed, and in the English version, only those in English).
The Senior Data Associate supports the Clinical Program and acts as the GDS DMS Study Lead in the execution of assigned data management tasks. The GDS DMS Operations Sr. Data Associate role is a Study Lead role. The Sr. Data Associate participates in all study-related data management activities, including Protocol review, eCRF development, Data Management Plan development, Data Validation Plan development, reconciliations, and the delivery of complete, correct, and consistently fit-for-purpose study datasets for statistical analysis.
Job Responsibility:
Draft Case Report Form (eCRF) in a concise, self-explanatory, and user-friendly format
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 appropriate ongoing/periodic data validation activities
Draft data transfer specifications
Conduct SAE reconciliation activities
Maintain data transfer calendar requirements
Post listings/reports/profiles to study file locations
Reconcile external 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 aimed at expanding Global Data Science and Data Management Science capability in a designated area of expertise
Requirements:
MA degree preferred, or BA/BS degree with a focus in statistics, computer science, life science, or related scientific discipline
2+ years of experience in clinical development, including technical experience within and outside of Data Management, with MS
5+ years with BS
Decision Making, Critical thinking and Problem Solving
Influence, Cross-Functional Collaboration and Organizational Awareness
Agility and Proactivity
Leadership
Communication
Strategic Thinking and Planning
Operations
General data management science skills
What we offer:
company-sponsored medical, dental, vision, and life insurance plans