Clinical Operations Quality Engineer - Grenoble, France - Kayentis
Description
KAYE
NTIS is a software solutions provider specialized in clinical trials.
Our c ore competence is in patient data capture and processing solutions (eClinical Outcome Assessments = eCOA) and
we a re now expanding towards Decentralized Trials functionalities.
With 16 years of global experience in eCOA, Kayentis has supported more than
260 clinical trials in
79 countries with
more than
90,000 patients. Its head office is located in Meylan, near
Grenoble (France), Kayentis is also present in
Bosto
n (USA) and
Tokyo (Japan).
Joining Kayentis' teams means choosing a fast-growing company committed to improving clinical trials and the
well-
being of its employees.
KAYE
NTIS is growing Develop your career with us
Join an international, cohesive and dynamic team and d
evelop new skills
For more information about
Kayentis, visit our career pa
ge, or have a look at our employee satisfaction survey results.
**Clinical Operations Quality Engineer M/F
The Clinical Operations Quality Engineer permanent position **is based in Meylan (Grenoble).
YOUR ROLE:
As part of Kayentis Quality & Regulatory team, you contribute to the quality and reliability of
Kayentis Solutions by ensuring clinical study projects follow Good Clinical Practices and Kayentis
Quality Management System processes.
Participate in the maintenance, continuous improvement, and training of processes related to
the provision of services, from study conception and validation through closure
Owns the deviation and issue management processes and its continuous improvement. Coach
study teams on deviations and issue handling
Assess issues for possible escalation into Problems and CAPAs; can lead or participate in CAPA
teams
Qualify, monitor and audit subcontractors and suppliers involved in the provision of services
Support client audits and client inspections
Escalate issues with Client Governance and Management as necessary
Track, trend and report KPIs on deviations and process quality
YOUR PROFILE:
Master 1 or Master 2 level or equivalent in quality or clinical management
Professional experience > 2 years in quality in a life science regulated environment
Experience managing deviations or quality management system processes
Excellent verbal communication and writing skills
Customer-oriented
Fluent in English
Preferred:
Experience in the pharmaceutical, medical device, or clinical field
Deviation and CAPA Management
YOUR BENEFITS:
Flexible working hours
Bonuses
Meal vouchers
Bike allowance
**Are you interested in this opportunity?
Plus d'emplois de Kayentis
-
Support Engineer
Grenoble, France - il y a 3 jours
-
Clinical Data Manager
Grenoble, France - il y a 3 jours
-
Project Information Management Lead F/H
Meylan, Isère, France - il y a 3 semaines
-
Data Manager Associate
Grenoble, France - il y a 3 semaines
-
Clinical Project Manager Setup M/F
Meylan, France - il y a 2 semaines
-
Support Technician
Grenoble, France - il y a 2 semaines