Indication Package Project Manager, Linguistic Validation & eCOA in Kirkland

The Linguistic Solutions team at IQVIA is seeking an experienced Project Manager with expertise in linguistic validation and eCOA to provide project management support for internal and client-funded indication package projects encompassing translation, linguistic validation, and eCOA migration and implementation.

The ideal candidate will have a strong background in project management, technical proficiency in eCOA systems, and an understanding of COA licensing and linguistic validation processes.

Responsibilities

• Build and maintain strong relationships with internal and external stakeholders and clients.
• Lead and manage end-to-end indication package projects encompassing translation, linguistic validation, and eCOA migration and implementation, ensuring timely and successful delivery against agreed package plans and dependencies that support downstream study planning and scoping.
• Lead and implement policies, procedures and/or actions for the purpose of improving efficiency and providing direction for meeting the team's objectives.
• Evaluate existing COA and eCOA content and indication requirements to determine translation, linguistic validation, and migration needs, including text, graphics, and multimedia elements.
• Oversee the extraction, translation, linguistic validation, and integration of high volumes of content across languages and scales/questionnaires, working closely with translators, linguistic experts, and internal eCOA team members.
• Implement rigorous quality assurance procedures to validate the accuracy, consistency, and functionality of translated content within the eCOA platform.
• Collaborate with multiple eCOA providers and technical teams to coordinate provider-specific requirements and ensure seamless integration of translated content into new or updated eCOA systems, maintaining the integrity of measurement properties.
• Ensure that all translation and migration activities comply with regulatory requirements and industry standards for clinical research and eCOA implementation.
• Identify and resolve any issues or challenges that arise during the migration process, leveraging problem-solving skills and technical expertise.
• Document all aspects of the indication package translation and migration process, including methodologies, validation procedures, regulatory compliance records, and issued certificates.
• Communicate effectively with internal and external stakeholders, including clients, eCOA providers, Linguistic Validation team members, finance, team managers, project managers, project teams, other vendors, and translators, regarding indication package status, deliverables, dependencies, and challenges.
• Manage multiple, parallel, high-volume indication package projects simultaneously.
• Follow company and department standard operating procedures.
• Work with Team Leads to help in the training and development of relevant guidance documents.

Required Knowledge, Skills and Abilities

• Bachelor's degree.
• Minimum 3 years of project management experience in translation, linguistic validation, and eCOA migration or implementation within the life sciences or language services industry.
• Excellent written and verbal communication skills.
• Fluency in English is essential; an additional language would be a strong asset.
• Strong grasp of project management techniques required.
• Ability to follow instructions/guidelines, work independently, and use own initiative.
• Experience working with CAT Tools would be highly advantageous.
• Ability to establish and maintain effective working relationships with co-workers, managers, and clients with demonstrated cultural and emotional intelligence.
• Meticulous attention to detail to ensure accuracy and consistency in translated content and project documentation.

Additional Information

The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.