Associate Director, Data Management Processes, Training, and Inspection Readiness

Posted 7 months agoInactiveViewed

United States of AmericaPharmaceutical

Company:DSI

Location:United States of America

Seniority level:Director, 7 or more years

Experience:7 or more years

Skills:

Project ManagementGCPCommunication SkillsAnalytical SkillsWritten communicationComplianceInterpersonal skillsExcellent communication skillsProblem-solving skillsVerbal communicationTrainingCross-functional collaborationRisk ManagementTeam managementStakeholder managementProcess improvementData modelingData analyticsData managementChange Management

Requirements:

7 or more years training and compliance background and strong knowledge of FDA and EU regulatory requirements, industry audit processes, and Data Management best practices required. 7 or more years' experience in clinical data management experience in a medical device, pharmaceutical company, or similar environment (e.g., CRO); oncology, immunology, or complex disease preferred 7 or more years of working knowledge of Clinical trial data systems and/or EDC lab management tools is a preferred

Responsibilities:

Leads development and implementation of Data Management departmental strategy and solutions related to process development, improvement, and training. Lead and coordinate development of DM processes and templates and ensure consistent execution of tasks and activities across programs. Prepare internal teams for audits and compliance.