Indication Package Project Manager, Linguistic Validation & eCOA, IQVIA Language Solutions
Core
Manage end-to-end indication package projects covering translation, linguistic validation, and eCOA migration/implementation for internal and client-funded clinical research studies.
Role type
Senior Project Manager (Linguistic Validation & eCOA)
Builds
Translated and validated indication packages integrated into eCOA platforms
Domain
Clinical research / Life sciences / Linguistic services
Required skills
Project management, eCOA systems proficiency, linguistic validation processes, regulatory compliance, quality assurance, stakeholder management, content evaluation, migration strategy, documentation, problem-solving
Preferred skills
CAT tools experience, additional language knowledge, cultural intelligence
Technologies
eCOA platforms, CAT tools
Responsibilities
Lead and manage end-to-end indication package projects encompassing translation, linguistic validation, and eCOA migration and implementation; Evaluate existing COA and eCOA content to determine translation and migration needs; Oversee extraction, translation, and integration of high volumes of content across languages; Implement rigorous quality assurance procedures to validate translated content; Collaborate with eCOA providers and technical teams to ensure seamless integration; Ensure compliance with regulatory requirements and industry standards; Document all aspects of the translation and migration process.
Seniority
Senior, hands-on IC