Life Science

Senior Clinical Data Manager

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.

Your responsibilities:
– 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.

Your profile:
– 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 mdollat@axepta.com