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Job Reference:
127445326501406310432460
Job Views:
3
Posted:
10.02.2025
Expiry Date:
27.03.2025
Job Description:
We are a worldwide leader in specialized diagnostics in Hemostasis, Acute Care Diagnostics, Autoimmunity and Transfusion and transplant. In addition, we research, develop, and manufacture customized assays and biomaterials through our OEM business line.
As an integral part of Werfen, a global healthcare company dedicated to delivering the highest quality in vitro diagnostics products.
In Werfen, we are looking for a Clinical Studies Scientist II. His/her main tasks are:
1. Coordinate clinical studies execution in clinical sites worldwide.
2. Provide support to principal investigators and their team: on-site trainings, monitoring of sites and clinical data, manage study-related administration and logistics tasks.
3. Ensure that studies and data management are performed in compliance with GCP, Ethical and Regulatory frame.
Knowledge & Experience:
1. Required: Bachelor's degree (Diplomatura) in Life or Medical Sciences
2. Valuable: Any additional degree (PhD or MsC) higher than that required previously
3. Minimum 4 years experience in scientific/in IVD field or experience in managing clinical studies internationally
4. Experience in CRF/e-CRF and other recruitment documentation
5. Experience in clinical study monitoring, data management and analysis
6. Knowledge of Medical Device Regulatory framework, mainly CE and FDA
7. Knowledge in GCPs
8. Knowledge in immunoassay techniques and analyzers
9. Knowledge in biostatistics and Data management
10. Knowledge of basic software tools (Excel, Word, PowerPoint). Knowledge of SAP valuable
11. Fluency in English & Spanish and advanced knowledge of English.
Key Accountabilities:
1. Train study team on the relevant part of clinical studies
2. Ensure statistical plan is properly performed and followed.
3. Ensure data management plan is properly performed and followed.
4. Ensure study risk analysis plans is properly performed.
5. Ensure that CRFs (case report forms) are well designed, completed and collected.
6. Prepare documentation to submit project to EC/IRB (Ethical Committee) and follow up with them during the study.
7. 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.
8. Monitor the study throughout its duration. This activity may be done directly or managing the activity of a CRA/CRO.
9. Ensure that all study close-out activities are performed.
10. Manage clinical databases and data analysis.
11. Prepare final clinical study reports.
12. Develop all activities in compliance with GCP and under an ethical and regulatory frame.
13. Prepare study documentation for FDA pre-submissions and submissions, and for other regulatory agencies, as required.
14. Accountable for the clinical part in the projects cross-functional team.
Skills & Capabilities:
1. Attention to detail and accuracy
2. Able to apply general scientific methods and theoretical knowledge to tasks within one area of expertise
3. Teamwork and interpersonal skills. Flexibility in order to work with, and provide support for a number of people
4. Oral and written communication skills
5. Time management skills. Excellent organizational and multi-tasking skills
6. Thorough knowledge of design control processes and familiarity with quality standards as required
7. Excellent analytical skills
8. Able to work independently on the project with moderate guidance
9. Well organized, able to handle large data sets, and communicate results, problems, and progress to the supervisor, and within the group as required
10. Ability to adapt to R&D flexible and changing environment
11. Certain troubleshooting ability required
12. Reflects values of Werfen and OEM in the quality of work and working relationship
What we offer:
* A meaningful project that will impact the quality of laboratory medicine worldwide
* Multicultural and friendly team
* Exciting opportunities for professional development
* Ongoing training
* Social benefits: Canteen, nursery check, English training...
* Retirement Plan
Our Purpose: We contribute to the advancement of patient care around the world through innovative specialized diagnostics.
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