Clinical Studies en Barcelona.

Mision:

Coordinate clinical studies execution in world-wide clinical sites.

Provide support to principal investigator¿s and their team: on-site trainings, monitoring of sites and clinical data, manage study-related administration and logistics tasks.

Ensure that studies, data management and data analysis are performed in compliance with GCP, Ethical and Regulatory frame.

- 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.- Prepare study documentation for FDA pre-submissions and submissions, and for other regulatory agencies, as required.- Accountable for the clinical part in the projects cross-functional team

- PhD, MSc or BSC in Life or Medical Sciences (Medicine, Biology, Pharmacist¿)- Minimum 4 years¿ experience in scientific/in vitro diagnostic field.- 2 or more years¿ experience in managing clinical studies internationally.- Experience in EDC and recruitment documentation.- Experience in clinical study monitoring, data management and analysis.- Knowledge of Medical Device Regulatory framework. Mainly CE and FDA.- Knowledge in GCPs.- Fluency in English & Spanish.

• Formación: Licenciado
• Idiomas: Inglés: C1
• Conocimientos: ensayos clínicos
• Experiencia: 2 años

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