Work Selection AG
As a first-tier supplier to our renowned business partner Roche Diagnostics in Rotkreuz, we are currently looking for a motivated and dedicated Clinical Site Manager for a temporary assignment of 12 months, with high probability of extension.
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.
Tasks & 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
Must-Haves
* 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
* Min. 2 years of prior 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 skillsEffective time and financial management skills
* Ability to establish and maintain effective working relationships with coworkers, managers, and clients
Nice-to-Haves
* Experience in Pathology
Benefits
* Work with state-of-the-art tools on a modern campus featuring green spaces and an inspiring atmosphere
* Experience a work culture that promotes diversity and inclusion, where everyone feels valued
* Benefit from financial support for your professional development and further education
* Take advantage of unbeatable, year-round discounts with renowned retailers, over 200 top brands, as well as fleet discounts on new car purchases and consistent fuel discounts
* Become part of one of the most renowned pharmaceutical companies and actively help shape the future of healthcare
* Enjoy a selection of high-quality meals in modern staff restaurants
* Where applicable, benefit from on-site parking as part of a sustainable mobility concept
* Start with professional onboarding and a thorough introduction to your new role during the Welcome Days
* We offer you a long-term position and diverse development opportunities within the company
Are you interested? Don't hesitate and submit your complete application documents online today. We look forward to hearing from you!
Wir wertschätzen Vielfalt und begrüßen daher alle Bewerbungen unabhängig von Geschlecht, sozialer Herkunft, Religion, Alter und Identität. Zur leichteren Lesbarkeit und besseren Verständlichkeit verwenden wir nur eine Gender-Form. Selbstverständlich sind im jeweiligen Kontext alle Genderformen gleichermassen gemeint.
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