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Job Description
For our Swiss subsidiary in Global Human Health based in Lucerne, we are currently looking for a Sr. Clinical Research Associate who will be responsible for performance and compliance for the assigned protocols and sites in Switzerland.
As a Sr. Clinical Research Associate (m/f/d) and under the supervision of the CRA Manager, you will ensure compliance of the studies conducted with ICH/GCP and country regulations, company policies and procedures, quality standards as well as adverse event reporting requirements internally and externally. You will act as the primary point of contact for the study sites and the site managers throughout all phases of the clinical research studies, taking overall responsibility of the allocated sites. On this rile you will actively develop and expand the territory for clinical research, finding and developing new sites and you will act as the subject matter expert for monitoring processes and systems.
THE PRIMARY ACTIVITIES INCLUDE BUT ARE NOT LIMITED TO:
Primary site contact and responsible for site management and monitoring activities throughout all study phases from validation to close-out
Assisting the allocated sites with all open matters and requests (remote and on-site)
Execution of risk-based monitoring at the study sites
Collection of regulatory documents and management of data in various clinical trial systems
Ensuring study conduct is in compliance with all relevant regulations and standards
Qualifications:
Bachelor’s or Master’s Degree in Biology or in subject with a natural science background
Minimum 3-4 years of direct site management (monitoring) experience in a (bio)pharmaceutical company or CRO
Experienced in the day-to-day business of a Clinical Research Associate
Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & swiss clinical research laws and guidelines
Enjoys a high level of personal responsibility and readily supports site staff on-site including the required travels
High affinity in examining medical data and source documents
Detail-oriented and efficient in time management and ability to prioritize
Outstanding communication and presentation skills
Ability to work highly independently across multiple protocols, sites and therapy areas
Fluent German and English knowledge, both written and spoken. French or Italian knowledge is advantageous
CITYBAY, LUCERNE
Current Contingent Workers apply
*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
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