Intuitive Surgical Careers
Clinical Data Manager
Primary Location: United States-California-Santa Clara County-Sunnyvale
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Primary Function of Position:
The Clinical Data Programmer/Manager role is responsible for CRF/eCRF design, EDC creation, validation, administration, user training and support for data management for active studies. Other responsibilities may include working closely with clinical project managers to develop CRF/eCRF for clinical studies, develop database reports and data listings and give guidance on field specifications in study development phase. This person will work closely with the clinical affairs group including project managers, clinical research administrators and statisticians. They will also interact with site coordinators and field clinical staff for query resolution according to protocol requirements.
- Develop clinical study data specifications, including CRF design, user requirements, edit rules/checks and query logic
- Provide clinical data management support for study operations and analysis groups
- Assist in defining and/or create data listings, summary table validation, data specifications and/or process data transfers in preparation for statistical review and/or data management audit
- Experience with validation of EDC systems from a study level (not IQ/OQ validation, more PQ for individual studies). Should have experience creating study requirements, test cases, and UAT documentation.
- Experience with clinical data transfers between systems and creation of Data Transfer Agreements (DTAs) between external data sources
- Administration of existing EDC systems for multiple studies
- Training users to user EDC systems. Includes create of training documentation and running training sessions for end users.
- Ideally this person will have medical knowledge as pertaining to medical devices for surgery. This will help to understand CRF design and purpose and interpret Study manager/protocol requirements to efficient EDC design.
- 2-5 years of experience building EDC study/CRFs. Bachelor's degree in Science, Computer Science, Engineering or related field.
- Experience with ClinCapture EDC system a plus
- Working knowledge of Good Clinical Practices, Good Manufacturing Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.
- Working knowledge of Clinical database applications such as EDC and CTMS.
- Excellent communication skills (written and verbal)