Our client in Lausanne, Switzerland is looking for a Data Manager to join their team who has approximately 5 years’ experience in clinical data management, with strong experience using major EDC systems and related tools and technologies.
Job Description
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. DAY TO DAY RESPONSIBILITIES • Define and manage Clinical Data Management timelines on multiple studies or programs
Responsibilities
- 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.
- Prepare data management plans, data validation plans and other study specific procedures and guidelines in compliance with standard processes and SOPs
- Ensure appropriate study specific training is provided to assigned study teams and documented
- Ensure ongoing and timely data capture and data cleaning, including external data sources
- Provide/coordinate 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
- Lock, transfer and archive databases.
- Ensure adherence to GCP, regulatory guidelines, standard processes and SOPs.
Requirements
- Minimum 5 years’ experience in data management
- Strong experience using EDC systems
- Experience with Metadata
- Master’s Qualification
- Fluent in English and French
- PhD Qualification