Senior Project Manager

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Oversee the delivery of localization for clinical outcome assessments and electronic Clinical Outcome Assessment programs across various clinical trials.

• Act as the primary operational liaison for incoming localization and eCOA inquiries, coordinating project initiation.

• Create and manage project plans, requirements, timelines, deliverables, risks, and resource allocations for multiple simultaneous studies.

• Facilitate collaboration between client stakeholders, study teams, localization experts, technology teams, copyright holders, vendors, and other partners.

• Evaluate the readiness of questionnaires, translations, licensing, and supporting assets prior to translation and eCOA migration.

• Manage copyright licensing, source-content assessment, translation preparation, multilingual deliverables, content adjustments, and version control.

• Supervise automation-driven eCOA questionnaire migrations and assess outputs for linguistic, formatting, technical, and content-readiness challenges.

• Identify and document migration issues, assist in root-cause analysis, suggest corrective measures, and relay feedback to technology teams.

• Track quality, timelines, review processes, productivity, and stakeholder satisfaction through dashboards and status updates.

• Ensure complete, accurate, version-controlled, and audit-ready documentation is maintained in SharePoint and document management systems.

• Recognize opportunities for process enhancements to minimize bottlenecks, maximize content reuse, expedite migration timelines, reduce manual tasks, and standardize procedures.

• Assist in the validation and implementation of automation, artificial intelligence, and emerging technologies.

• Provide project leadership and direction to cross-functional contributors while fostering quality, collaboration, and ongoing improvement.

⛳️ Requirements

• A Bachelor’s degree in Life Sciences, Languages, Translation, Clinical Research, Healthcare Administration, Project Management, or a related field.

• A minimum of five years of pertinent experience in clinical localization, clinical operations, clinical technology, or project management within the pharmaceutical, biotechnology, CRO, or similar sectors.

• Proven experience managing multiple concurrent projects, timelines, risks, deliverables, and cross-functional stakeholders in a dynamic, matrixed environment.

• Strong grasp of multilingual content development, translation, and localization processes.

• Exceptional communication, stakeholder management, organizational, analytical, and problem-solving abilities, with a keen attention to detail.

• Familiarity with SharePoint, document management systems, collaboration tools, and project tracking software.

• Capability to work independently, prioritize competing tasks, and maintain complete, accurate, and audit-ready project documentation.

• Direct experience with Clinical Outcome Assessments, electronic Clinical Outcome Assessments, and questionnaire migration projects is highly desirable.

• Background in copyright licensing, content acquisition, translation preparation, and version management processes is preferred.

• Knowledge of eCOA platforms, localization technologies, translation management systems, or similar clinical technologies is an advantage.

• Experience in reviewing migration outputs, documenting defects, conducting root-cause analysis, or supporting quality validation activities is beneficial.

• Background in supporting automation, artificial intelligence, or clinical technology pilot initiatives is preferred.

• PMP or an equivalent project management certification is advantageous.

• Legal authorization to work in the country where the position is located.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.