Who is Aixial Group ?

Aixial Group is a CRO (Clinical Research Organization), specialized in Life Science. We work with laboratories to provide technical support on clinical projects from phases I to IV and post market.

Since 2014, we have been part of the Alten family. We are developing our activities in Switzerland, France, Belgium, Czech Republic, Denmark, UK, US…with even more prospects for expanding internationally.

Aixial Group, operates in outsouring, insourcing, for pharmaceutical, cosmetic, medical device, biotechnology, nutrition,… activities in clinical operations, regulatory affairs, quality, biometrics, pharmacovigilance, HEOR…

Aixial Group continues to grow, and to recruit in the clinical trial professions. Come and join us, and discover our site to follow the news of our offers.

The Team of Aixial Group Switzerland is looking for his next Senior Clinical Data Manager (M/F) !

Reporting to the Head of the Data Management Department, and working in close collaboration with clinical research teams, you will manage data from international clinical trials of various phases.

ACTIVITIES (non-exhaustive list) :

• Design and implementation of database structures
• Programming and validation of consistency checks
• Definition of standards and capitalisation of data for transfer to studies
• Creation of the e-CRF study design
• Drawing up data validation plans
• Validation of Edit Checks
• Data base lock
• Drafting the report on decisions and actions relating to the data before closing the database
• Coordinating data validation in partnership with the medical and statistical teams

PROFILE REQUIRED :

• Master Degree in Data Management, bioinformatics…
• > 7 years’ experience in data management in a CRO or laboratory environment
• Proficiency in SAS, Medidata Rave, any other tool is a plus
• Mastery of clinical trial methodology
• Knowledge of regulations (GCP, ICH, etc.) and MedDRA dictionary
• Professional written and spoken English. Any other language is a plus

You are available in short time.

You are able to work in remote or be based in Switzerland