Clinical Site Manager
(m/f/d)
Freelance/temporary employment for a project Zug Start date: asap Reference number: 845034/1
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Project information
1. The Clinical Research Associate will design, plan, coordinate, and conduct all activities involved in initiating, monitoring, and completing clinical research studies for in vitro diagnostics
Responsibilities
2. Ensuring studies are conducted and documented in accordance with the study protocol, standard operating procedures, good clinical practices and other applicable regulatory requirements
3. Validating product performance claims
4. Supplying data for critical Regulatory submissions
5. Defining the functional and clinical utility of investigational products
6. Obtaining opinions and input regarding investigational products from laboratories or customers, who may be considered key opinion leaders
7. The CRA is responsible for adhering to the policies of the quality system and achieving quality objectives through daily actions
8. Performing or coordinating aspects of clinical studies including site selection, study initiation, site monitoring, and study closeout
9. Maintaining communication with study investigators to ensure studies are completed in a timely fashion and ensuring that study objectives are met
10. Interfacing with cross functional staff to support post launch activities
11. Reviewing cases with investigators to resolve discrepancies
12. Ensuring that studies adhere to FDA regulations, Good Clinical Practices, IVD directives, and Roche policies and procedures
Profile
13. Bachelor’s degree (Masters and PhD also ok) in science or relevant field, Medical technology degree preferred, but not required if R&D background is adequate
14. Preferably experience in clinical research or laboratory research
15. Solid relevant experience
16. Basic knowledge of, and skill in applying, applicable clinical research regulatory requirements (, Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines)
17. Excellent oral and written communication skills in English
18. Excellent planning, organizing, and interpersonal skills
19. Ability to work independently, make sound decisions, and to analyze and solve problems
20. Medical laboratory experience preferred
21. Good therapeutic and protocol knowledge
22. Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable)
23. Organizational and problem-solving skills
24. Effective time and financial management skills
25. Ability to establish and maintain effective working relationships with coworkers, managers, and clients
Benefits
26. A very renowned company
27. You will work in an international environment