Our client in Lausanne, Switzerland, is looking for an experienced Clinical Data Manager to join their teams.
- Hold a Master Degree ?
- Have approximately 5 years of experience in clinical data management, with strong experience using major EDC systems and related tools and technologies ?
- Have a fluent English level - written and spoken ?
Then, this might be the next step in your career !
The consultant will be accountable for the quality and timelines of all Data Management deliverables for assigned clinical trials, including trials for which data management activities are outsourced to external providers. The consultant will provide accurate and consistent clinical data to support internal decision making process. They will be a key member of the clinical study team, and responsible for performing and/or overseeing the set-up, maintenance, control, cleaning and validation of clinical study databases, in compliance with SOPs and regulatory guidelines. They will be working closely with clinical trial managers, Medical directors and Biostatisticians and provides efficient data management support to the study team.
- You define and manage Clinical Data Management timelines on multiple studies or program
- You coordinate/perform CDM activities for assigned studies/programs, including eCRF design, EDC system set up, user acceptance testing, users training, database release, data review and query generation and data coding
- You prepare data management plans, data validation plans and other study specific procedures and guidelines in compliance with standard processes and SOPs
- You ensure appropriate study specific training is provided to assigned study teams and documented
- You ensure ongoing and timely data capture and data cleaning, including external data sources
- You provide/coordinate data management support to study teams to support timely and ongoing data review and monitoring
- You ensure study timelines are met and data quality is according to high industry standards
- You lock, transfer and archive databases
- You ensure adherence to GCP, regulatory guidelines, standard processes and SOPs
- You hold a Master Degree. A PhD Qualification is a plus.
- You have approximately 5 years of experience in clinical data management.
- You have a strong experience using EDC systems.
- You are skilled in Metadata.
- You have a fluent English level - written and spoken. French is a plus.