Les 41 meilleures offres d'emploi : en tant que networking, , à Mollet Del Vallés (février 2026)

Clinical Studies Scientist II

il y a 15 heures

Lliçà d'Amunt

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., • 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. Networking / Key Relationships Mainly with R&D, Regulatory Affairs, and Design Quality and Operations colleagues. Minimum Knowledge & Experience required for the position: Education: • Required: Bachelor's degree (Diplomatura) in Life or Medical Sciences (Medicine, Biology, Pharmacist…), • Degree may be substituted by relevant skills and work experience., • Experience in CRF/e-CRF and other recruitment documentation, • Experience in clinical study monitoring, data management and analysis., • Knowledge of Medical Device Regulatory framework. Mainly CE and FDA., • Knowledge in GCPs., • Knowledge in immunoassay techniques and anlysers., • Knowledge in biostatistics and Data management., • Knowledge of basic software tools (Excel, Word, PowerPoint). Knowledge of SAP., • Language: Fluency in Spanish or Catalan. Advanced knowledge of English (reading, speaking and writing ) Skills & Capabilities: • Attention to detail and accuracy, • Able to apply general scientific methods and theoretical knowledge to tasks within one area of expertise., • Teamwork and interpersonal skills. Flexibility in order to work with, and provide support for a number of people., • Oral and written communication skills., • Time management skills. Excellent organizational and multi-tasking skills., • Thorough knowledge of design control processes and familiarity with quality standards as required., • Excellent analytical skills., • Able to work independently on the project with moderate guidance., • Well organized, able to handle large data sets, and communicate results, problems, and progress to the supervisor, and within the group as required., • Ability to adapt to R&D flexible and changing environment., • Certain troubleshooting ability required., • Reflects values of Werfen and OEM in the quality of work and working relationship.

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