Clinical Data Manager
My client is an innovating, dynamic and growing international medical device company currently expanding their clinical team in Switzerland, Geneve Canton.
Due to this growth my client is looking for a Clinical Data Manager.
Your Responsibilities :
– Contribute to the definition and the implementation of EDC or paper case record form of clinical studies.
– Be in contact with the global authorities.
– 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)
– Act as EDC representative
– Setup and lead clinical trial data and EDC specifications, EDC design, edit checks programming
– Maintain current awareness of regulations, guidance documents (Data Management Plan, Data Validation Plan…), advisory committees, industry standards, appropriate archiving, GCP and interna SOPs.
– Manage user access to the clinical database. Ensure appropriate training is received.
– 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.
– Participate in the development and maintenance of Data management SOPs.
Your Profile :
– Minimum B.Sc. degree in Biochemistry, Microbiology, Pharmacy, Biological Sciences or Related Pharmaceutical Science ;
– Minimum of 4 years of experience in clinical data management.
– Strong knowledge of CDISC standards is required ;
– Experience in biostatistics and/or SAS programming is a plus ;
– Strong critical thinking and problem solving skills ;
– Able to rapidly adapt to changing environment and circumstances ;
– Fluent in English and French.