My client is an innovating, dynamic and growing international medical device company currently expanding their clincal team in Switzerland, Geneve Canton.
Due to this growth my client is looking for a Clinical Data Manager.
Your Responsibilities :
Ø Contribute to the definition and the implementation of EDC or paper case record form of clinical studies.
Ø Be in contact with the global authorities.
Ø Leverage EDC development outsourced to external partners and manage related activities including setting up of data transfer agreements and appropriate clinical database reconciliation with internal database (ie safety database)
Ø Act as EDC representative
Ø Setup and lead clinical trial data and EDC specifications, EDC design, edit checks programming
Ø Maintain current awareness of regulations, guidance documents (Data Management Plan, Data Validation Plan…), advisory committees, industry standards, appropriate archiving, GCP and interna SOPs.
Ø Manage user access to the clinical database. Ensure appropriate training is received.
Ø work closely with clinical project manager to ensure quality of clinical data throughout the clinical study lifecycle to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review or final database lock.
Ø Participate in the development and maintenance of Data management SOPs.
Your Profile :
Ø Minimum B.Sc. degree in Biochemistry, Microbiology, Pharmacy, Biological Sciences or Related Pharmaceutical Science ;
Ø Minimum of 4 years of experience in clinical data management.
Ø Strong knowledge of CDISC standards is required ;
Ø Experience in biostatistics and/or SAS programming is a plus ;
Ø Strong critical thinking and problem solving skills ;
Ø Able to rapidly adapt to changing environment and circumstances ;
Ø Fluent in English and French.