Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters are in Barcelona, Spain and our Technology Centers are located in the United States and Europe. Worldwide sales exceeded €2.2 billion in 2024, and our workforce is more than 7,000 strong. JOB SUMMARY Coordinate clinical studies execution in clinical sites world-wide . Provide support to principal investigators and their team: on-site trainings, monitoring of sites and clinical data, manage study-related administration and logistics tasks. Ensure that studies and data management are performed in compliance with GCP, Ethical and Regulatory frame. Key Accountabilities Develop clinical study design. Write clinical study protocols. Write study monitoring plan. Train study team on the relevant part of clinical studies.
Ensure statistical plan is properly performed and followed. Ensure data management plan is properly performed and followed. Ensure study risk analysis plans is properly performed. Ensure that CRFs (case report forms) are well designed, completed and collected. Prepare documentation to submit project to EC/IRB (ethical Committee) and follow up with them during the study. Conduct site initiation visits in the clinical sites for the purpose of training site personnel about the protocol, study procedures, patient recruitment, reporting procedures, GCP and regulatory requirements. Monitor the study throughout its duration. This activity may be done directly or managing the activity or a CRA/CRO. Ensure that all study close-out activities are performed. Manage clinical databases and data analysis. Prepare final clinical study reports. Develop all activities in compliance with GCP and under an ethical and regulatory frame.
📌 Clinical Studies Scientist II (Cataluña)
🏢 Actual Talent
📍 Cataluña
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