Clinical Site Manager (m/f/d)

Clinical Site Manager (m/f/d) -RZ- Clinical Research/Laboratory research/GCP/International Conference on Harmonization (ICH)/English

Project:
For our customer Roche Diagnostics International AG based in Rotkreuz we are looking for a qualified Clinical Site Manager.

Background:
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.

The perfect candidate has a degree in Medical technology with first professional experiences in clinical research or laboratory research. Additionally, the person brings basic knowledge of, and skill in applying, applicable clinical research regulatory requirements as well as excellent oral and written communication skills in English.

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 (ie, 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

Nice to Have:
. Experience in Pathology

Reference No .: 924498
Role: Clinical Site Manager (m/f/d)
Industry: Pharma
Workplace: Rotkreuz
Workload: 80 - 100%
Start: Asap (latest Start Date: December 1st, 2025)
Duration: Unlimited
Deadline: October 23rd, 2025

If this position has sparked your interest, please send us your complete application dossier via the link in this advertisement.

About us:
ITech Consult is an ISO 9001:2015 certified Swiss company with offices in Germany and Ireland. We specialize in placing IT candidates for contract assignments. Founded in 1997 by IT professionals, we understand the importance of providing professional support in project search and execution.