Overview

In this role you support study teams by organizing and maintaining the Study Master File (SMF) and coordinating practical study tasks in line with company policies, SOPs, and regulatory requirements. You will work within the Functional Solutions team, dedicated to a sponsor, and help ensure GCP compliance and smooth study operations. You’ll interact across the study team, contribute to audits and regulatory inspections, and support documents, meetings, and reporting. This is a hands-on, cross-functional role with meaningful impact on trial quality and timelines.

Compensaciones / Incentivos

- opportunities for personal and professional growth
- collaborative environment
- values-driven culture (Trust, Quality, Passion, Flexibility, Sustainability)
- making a difference in patients' lives

Responsabilidades

- Initiate, maintain and archiving of the SMF with GCP compliance
- Set up and maintain study information in CTMS per delegation
- Maintain electronic files and prepare Investigator’s File per CRA directions
- Serve as SMF point of contact and support Lead CRA/PM




- Coordinate study supplies and assist with trial-related documents/tools/templates
- Assist in status reporting and meeting logistics; take and distribute minutes
- Support audits and regulatory inspections activities
- SMF completion and shipment preparation to sponsor; collect appendices for final study report
- Contribute to study team meetings and organizational routines to improve processes
- Support regulatory submissions (IEC/IRBs/CA) and contract management with sites
- Assist with document translations; support CRA/PM with remote monitoring activities

Requisitos principales

- Bachelor’s Degree preferred
- Knowledge of GCP/ICH guidelines
- Good written and communication skills
- Good organizational and software/computer skills
- Ability to work in a fast-paced environment with changing priorities

- Strong communication
- Organizational diligence
- Team collaboration
- CTMS setup and maintenance
- SMF management
- Electronic file maintenance

📌 Clinical Trial Associate (Barcelona)
🏢 Trial Form Support
📍 Barcelona