Clinical Studies Scientist II

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. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong. Overview Coordinate clinical studies execution in clinical sites worldwide. Provide support to principal investigators and their team: on-site training, 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. Responsibilities Key Accountabilities 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 are 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. Internal Networking Mainly with R&D, Regulatory Affairs, and Design Quality and Operations colleagues. Qualifications Minimum Knowledge & Experience required for the position Required: Bachelor's degree (Diplomatura) in Life or Medical Sciences (Medicine, Biology, Pharmacist…) Degree may be substituted by relevant skills and work experience. Valuable: Any additional degree (PhD or MsC) higher than that required in the previous section. Years of experience Minimum 4 years’ experience in scientific/in vitro diagnostic field or experience in managing clinical studies internationally. Min knowledge 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 analyzers. Knowledge in biostatistics and Data management. Knowledge of basic software tools (Excel, Word, PowerPoint). Knowledge of SAP preferred. 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. Travel Requirements (%) Up to 15% of time. What we offer A meaningful project that will impact the quality of laboratory medicine worldwide. Multicultural and friendly team. Ongoing training. Social benefits: Canteen, nursery check, English training... Retirement Plan. If you are interested in constantly learning and being challenged on a daily basis, we encourage you to submit your resume or CV. Werfen appreciates and values diversity. We are an Equal Opportunity/Affirmative Action Employer M/F/D/V. #J-18808-Ljbffr