| My client is an innovating, dynamic and niche international biopharma company currently expanding their team around Lausanne. |
Due to this growth my client is looking for a Senior Clinical Data Manager with strong experience with EDC system and leading data studies.
– Ensure and lead Clinical Data Management timelines on multiple studies or programs
– Manage CDM activities for assigned studies/programs, including eCRF design, EDC system set up, database release, data review and query generation and data coding.
– Ensure training for data base user and study team
– Coordinate data management plans, data validation plans and other study specific procedures
– Ensure ongoing and timely data capture and data cleaning, including external data sources
– Establish data management support to study teams to support timely and ongoing data review and monitoring
– Ensure study timelines are met and data quality is according to high industry standards
– Ensure adherence to GCP, regulatory guidelines, standard processes and SOPs.
– Scientific Master level with an experience of 5 years minimum in clinical data management
– Strong experience with EDC system.
– Experience leading data management studies and teams to timely deliver quality databases that meet regulatory requirements
– Good planning, organizational and communications skills
– Fluent in English, good knowledge of French an asset
For more details, please contact Marine Dollat at email@example.com