Clinical Site Manager
Direct message the job poster from Actalent
We are seeking a Clinical Site Manager for our client based in Rotkreuz. You will design, plan, coordinate, and conduct all activities involved in initiating, monitoring, and completing clinical research studies for in vitro diagnostics.
Please note that for this role, there is 25-30% travel within Europe.
Key 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
Qualifications
* 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)
* Experience in Pathology is a nice to have
* 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)
* Excellent oral and written communication skills in English
Job Type: 12 month contract with probability of extension
Start Date: 01.12.2025
Home Office: max. 40%
Travel: 25-30% within Europe
While we appreciate every application, please note that due to the high volume of responses, we may only be able to contact shortlisted candidates.
Please note that we can only consider EU/Schengen applications.
Seniority Level
Associate
Employment Type
Temporary
Job Function
Science and Research
Industries
Pharmaceutical Manufacturing and Biotechnology Research
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