Role
Lead study integration for clinical data management, ensuring quality and compliance in trial data components such as eCRFs, integrations, and reports. Responsibilities include developing program plans, managing cross-functional coordination, risk mitigation, change control, and overseeing validation and audit readiness. The role involves direct leadership of complex trials, process improvement initiatives, and team development.
Requirements
Bachelor's degree with 8+ years in clinical data management or related fields, including 2 years of people management; or an advanced degree with 4+ years of relevant experience, including 2 years of leadership.
High-Value
Experience with clinical trial lifecycle, GxP standards, validation, audit preparation, and data systems integrations; familiarity with automation tools and programming interfaces; strong stakeholder engagement skills.
Collaboration
Collaboration involves Clinical, DI&A/IT, service providers, and other stakeholders.
Work setup
hybrid with 10% travel.
#J-18808-LjbffrAssociate Director - Study Integration Manager, Data Integration and Automation - Hybrid in pa at Unknown Company
This position is listed as full time and hybrid.