.JOB OVERVIEW RESPONSIBILITIES Lead, mentor, and manage a team of eCOA Migration Project Managers and Screen Review Specialists, fostering a collaborative and high-performance work environment.
Oversee the end-to-end process of eCOA implementation and translation migration projects, ensuring they are completed on time, within budget, and to the highest quality standards.
Develop and implement strategic plans for eCOA migration and screen review processes, aligning with organizational goals and industry best practices.
Ensure rigorous quality assurance processes are in place for the translation and migration of eCOA content, maintaining accuracy, consistency, and regulatory compliance.
Act as an SME and the primary point of contact for internal and external stakeholders, including clients, translators, and internal and external eCOA providers, to ensure clear communication and successful project outcomes.
Continuously evaluate and improve processes for eCOA migration and screen review, leveraging feedback, industry trends, and technological advancements.
Ensure all eCOA implementation and translation migration activities comply with relevant regulatory requirements and industry standards.
Manage resource allocation, budgeting, and scheduling to optimize project efficiency and team productivity.
Oversee the documentation of project plans, review findings, test results, and regulatory compliance records, ensuring thorough and accurate records are maintained.
Provide training and professional development opportunities for team members to enhance their skills and knowledge in eCOA implementation and translation migration.
Manage and run various reports on KPIs, risk management, contingency plans, and QC outcomes, resources, and software utilization.
Lead initiatives focusing on organization and department process improvements and efficiencies.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES Bachelor's degree in a relevant field (e.G., Life Sciences, Information Technology, Project Management, Linguistics).
Minimum of 4-5 years of experience in project management, clinical research, eCOA implementation, or translation and localization, with managerial experience.
Excellent written/verbal communication skills; fluency in English is essential, an additional language would be a strong asset.
Strong understanding of eCOA platforms, databases, data structures, and translation technologies.
Extensive experience in managing complex projects, with a demonstrated ability to deliver results on time and within budget.
PMP or similar certification is a plus.
Experience working with TMS and CAT Tools.
Ability to present data with visualization.
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 the highest quality and accuracy in all aspects of eCOA migration and screen review