Clinical Trials Coordinator – Pharma Sector

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Sanofi is a global healthcare leader committed to improving people’s lives worldwide. We provide innovative therapeutic solutions to address the evolving needs of patients, from rare diseases to chronic conditions. With a strong presence in over 100 countries and a rich heritage of scientific discovery, Sanofi is dedicated to bringing life-changing medicines and vaccines to those who need them most. Join our dynamic team in Girona, Spain, and contribute to groundbreaking research that impacts global health.

Descripción del Trabajo

We are seeking a highly organized and detail-oriented Clinical Trials Coordinator to join our research and development team in Girona. In this pivotal role, you will be instrumental in the successful execution of clinical trials, ensuring adherence to protocols, Good Clinical Practice (GCP), and regulatory requirements. You will serve as a key point of contact for investigators, study participants, and internal teams, facilitating communication and managing essential documentation. This is an exciting opportunity for a professional passionate about clinical research to contribute to the development of new pharmaceutical therapies.

Responsabilidades Clave

• Coordinate all aspects of assigned clinical trials from study start-up through close-out, ensuring timely completion and quality data collection.
• Assist in the preparation, review, and submission of study-related documents, including protocols, informed consent forms, and regulatory submissions.
• Maintain accurate and up-to-date trial master files (TMF) and site master files (SMF) in compliance with regulatory guidelines.
• Facilitate communication between investigational sites, internal project teams, and external vendors.
• Support site selection, initiation, monitoring, and close-out visits as needed, working closely with Clinical Research Associates (CRAs).
• Track and manage study supplies, including investigational medicinal products (IMPs) and laboratory kits.
• Oversee the enrollment process and ensure proper collection of patient data, resolving data queries efficiently.
• Ensure all trial activities comply with company SOPs, GCP, and relevant national and international regulations.
• Provide administrative support to the clinical operations team, including scheduling meetings and preparing presentations.

Habilidades Requeridas

• Bachelor's degree in a life science, nursing, or a related healthcare field.
• Minimum of 2 years of experience in clinical research, preferably as a Clinical Trials Coordinator or equivalent role.
• Strong understanding of ICH-GCP guidelines and regulatory requirements for clinical trials.
• Excellent organizational skills and meticulous attention to detail.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
• Strong communication and interpersonal skills, both written and verbal, in English and Spanish.
• Ability to work independently and as part of a multidisciplinary team.
• Demonstrated ability to manage multiple tasks and prioritize effectively in a fast-paced environment.

Cualificaciones Preferidas

• Master's degree or higher in a relevant scientific discipline.
• Certification as a Clinical Research Coordinator (CRC).
• Experience with Electronic Data Capture (EDC) systems and Clinical Trial Management Systems (CTMS).
• Familiarity with local regulatory landscape in Spain for clinical trials.
• Knowledge of pharmaceutical drug development processes.

Ventajas y Beneficios

• Competitive salary and performance-based bonuses.
• Comprehensive health, dental, and vision insurance.
• Generous paid time off and holidays.
• Pension scheme contributions.
• Opportunities for professional development and continuous learning.
• Employee assistance programs.
• Dynamic and collaborative work environment.
• Opportunity to work on innovative global clinical trials.

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