Nous recherchons notre prochain Senior Clinical Data Manager H/F, dont les missions seront les suivantes (liste non exhaustive) :
* Concevoir le cahier d’observation et le recueil de données cliniques
* Rédiger le plan de data-management et de ses annexes (cahier des charges)
* Rédiger le plan de validation des données
* Réaliser la validation des études : Adresser et gérer les queries conformément au plan de validation
* Gérer et maintenir les eCRF
* Réaliser des programmes informatiques et produire des listing de données individuelles et des tables de données destinées à la revue médicale
* Proposer des process innovants et être support des initiatives du département
* Gel et verrouillage de la base de données cliniques
Compétences et formation requis :
* Master dans le secteur de la recherche clinique, en statistiques
* A partir de 5 ans d'expérience professionnelle minimum en tant que Clinical Data Manager
* Expérience avec les standards CDISC, STDM,..
* Expert/e dans l'utilisation du logiciel de gestion des données, y compris par exemple Medidata RAVE
* Expérience sur SAS recherchée (la programmation y serait un plus)
Compétences linguistiques :
* Un niveau courant (écrit et oral) en anglais
You are a highly skilled professional with passion for the world of Life Sciences and Clinical Research? You want to thrive in a dynamic and collaborative international environment where your expertise directly impacts people lives?
Come and join Aixial Group to contribute to shaping the future of clinical research!
Who Are we?
• We are one of the world’s leaders in CRO (Contract Research Organisation) with the commitment, expertise, and flexibility needed to deliver efficient clinical trials.
• We work with global pharmaceutical, biotech, cosmetic, medical device, and many other companies around the globe, providing them with innovative and scalable solutions.
• We are operating in 10 countries across 3 continents, bringing together over 1000 talented professionals dedicated to make a positive impact in the life sciences industry.
• We have been part of ALTEN Group since 2014 and are continuously exploring new opportunities to expand our activity worldwide. Why Join Us?
• Make a positive impact and be at the forefront of project:
You will be part of groundbreaking advancement in clinical research that has positive impacts on millions of people’s lives globally.
• Career Development:
People are our biggest asset. We are committed to empower our team continually and build a positive and supportive environment that fosters growth, flexibility, and teamwork. At Aixial Group, you will be coached and mentored throughout your journey to help you advance your professional and personal growth.
• Our commitment to Diversity, Equality, and Inclusion:
We aim to create a workforce which promotes dignity and respect, where individual differences are recognized and valued, and where each employee can give their best.
Gender equality is at the core of the development strategy of Aixial Group.
Aixial Group continues to grow, and to recruit in the clinical trial professions. Join us, and discover our website to follow the news of our offers: https://www.aixialgroup.com/join-us/
For more information: https://www.linkedin.com/company/aixialgroup/about/
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