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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 and 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
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 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 in science or relevant field (Master’s and PhD also ok). Medical technology degree preferred but not required if relevant background is adequate
Preferably experience in clinical research or laboratory research
Minimum 2 years of prior relevant experience
Basic knowledge of and skill in applying applicable clinical research regulatory requirements (e.g., Good Clinical Practice and ICH guidelines)
Excellent oral and written communication skills in English
Excellent planning, organizing and interpersonal skills
Ability to work independently, make sound decisions, and analyze and solve problems
Medical laboratory experience preferred
Good therapeutic and protocol knowledge
Computer skills, including proficiency in 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
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 a renowned pharmaceutical company 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 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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