Clinical Site Manager (m/f/d)
Project information
- 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
- Ensuring studies are conducted and documented in accordance with the study protocol, standard operating procedures, good clinical practices and other applicable regulatory requirements
- Validating product performance claims
- Supplying data for critical Regulatory submissions
- Defining the functional and clinical utility of investigational products
- Obtaining opinions and input regarding investigational products from laboratories or customers, who may be considered key opinion leaders
- The CRA is responsible for adhering to the policies of the quality system and achieving quality objectives through daily actions
- Performing or coordinating aspects of clinical studies including site selection, study initiation, site monitoring, and study closeout
- Maintaining communication with study investigators to ensure studies are completed in a timely fashion and ensuring that study objectives are met
- Interfacing with cross functional staff to support post launch activities
- Reviewing cases with investigators to resolve discrepancies
- Ensuring that studies adhere to FDA regulations, Good Clinical Practices, IVD directives, and Roche policies and procedures
Profile
- 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
- Preferably experience in clinical research or laboratory research
- Solid relevant experience
- Basic knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines)
- Excellent oral and written communication skills in English
- Excellent planning, organizing, and interpersonal skills
- Ability to work independently, make sound decisions, and to analyze and solve problems
- Medical laboratory experience preferred
- Good therapeutic and protocol knowledge
- Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable)
- Organizational and problem-solving skills
- Effective time and financial management skills
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients
Benefits
- A very renowned company
- You will work in an international environment
About Hays
With over 15 years of experience in the pharmaceutical and chemical industry as well as in biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – completely free of charge. Register with us and reap the benefits of interesting job offers that match your skills and experience.
Staffing process for freelance specialists
- Analysis of qualifications
- Telephone or personal interview
- Contact with customers
- Contract with Hays
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1. Analysis of qualifications
We carry out a detailed analysis of your technical qualifications on the basis of your CV, your application documents and your profile.
Contact at Hays
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