COA/eCOA Specialist

In this role, you will be responsible for managing and optimizing COA/eCOA systems for clinical trials. Your expertise will be vital in ensuring their smooth integration and effective implementation, which will be key to the success of our projects.

Full-time employment based in France

You will:

• Support project teams with instrument licensing, translation management, system specification, testing, and deployment activities.
• Perform instrument license research and support license acquisition and deployment activities.
• Support translation and localization activities, including language gap analysis and coordination with vendors.
• Support internal processes related to the implementation and use of COA/eCOA systems across clinical studies.
• Collaborate with project teams, clients, and vendors to facilitate the successful setup and delivery of COA/eCOA solutions.
• Provide input on training materials for sites and patients in line with study requirements.
• Monitor COA/eCOA vendor performance at the study level and escalate issues as appropriate.
• Coordinate integration activities between COA/eCOA platforms and other clinical systems (e.g., EDC, IRT/IxRS).
• Support oversight of COA/eCOA activities following system go-live.
• Assist in identifying and assessing risks associated with the implementation of COA/eCOA systems.
• Support training activities for project teams and other stakeholders.
• Contribute to vendor management, quality, and continuous improvement activities.
• Support business development initiatives, including proposals, client presentations, and vendor-related activities.

• College/University degree
• Prior industry experience in clinical research
• Experience of working with clinical data systems and COA/eCOA systems is a plus
• Advanced proficiency in MS Office applications
• Full working proficiency in English
• Excellent communication and time management abilities, with a strong desire to learn and a curious mindset

Make the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success.

Please submit your CV in English.

PSI is a leading Contract Research Organization (CRO) with about 30 years of experience in the pharmaceutical industry. Originated in Switzerland, PSI is a privately owned, full-service CRO with a global reach, supporting clinical trials across multiple countries and continents. Our reputation for being highly selective about the projects we undertake highlights our commitment to delivering high-quality, timely services across a broad spectrum of therapeutic indications.

At PSI, we foster an environment where a diverse range of colleagues feel welcomed and valued. Our inclusive culture is a cornerstone of our success, enabling us to attract and retain top talent globally.

We are not just about conducting clinical trials; we are about building a community where every team member has the opportunity to thrive and contribute to groundbreaking advancements in the pharmaceutical industry.

Originally posted on Himalayas