COA/eCOA Specialist

Company Description

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.

Job Description

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 Czechia

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.

Qualifications

• 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

Additional Information

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.