A recognized services organization is seeking a Sr. Technical Consultant to support clinical data review, analytics, and study technology initiatives using Medidata Clinical Data Studio and related tools.
About the Opportunity
Schedule: Monday to Friday
Hours: Standard business
Setting: Remote
Responsibilities:- Configure, support, and optimize Medidata Clinical Data Studio solutions
- Develop and maintain data review workflows, visualizations, and clinical data monitoring processes
- Support risk-based quality management initiatives through centralized data review and surveillance activities
- Develop custom reports, listings, and data review tools using Python and/or SASCollaborate with cross-functional stakeholders to identify data quality signals, trends, and risks across clinical studies
Qualifications:- At least 5 years of experience supporting clinical trials within a pharmaceutical, biotechnology, or CRO environment
- Bachelor's degree in Computer Science, Life Sciences, Biostatistics, Data Science, or a related field
- Hands-on experience with Medidata Clinical Data Studio (CDS)
- Experience with Python development and/or SAS programming
- Strong understanding of clinical trial processes and clinical data managementExperience working with EDC and clinical data review systems
- Knowledge of GCP and regulatory requirements governing clinical trials
Desired Skills:- Experience with Medidata Rave
- Experience with Medidata Detect
- Knowledge of CDISC standards, including SDTM and ADaMExperience supporting global clinical trials
- Familiarity with cloud-based analytics and reporting solutions
- Experience creating dashboards, visualizations, or automated clinical review tools
- Experience with risk-based monitoring and risk-based quality managementExperience with data visualization tools