Associate Senior Clinical Data Scientist
Bangalore, Karnataka, IN
INR 900K-1250K (estimate) Mid-level Full Time
Tasks
- Collaborate with CROs and regulatory authorities
- Create Define xml
- Create TFLs
- Create metadata specifications
- Develop data flow plans
- Develop eCRFs
- Ensure GCP documentation compliance
- Ensure GDP documentation compliance
- Ensure GPP programming compliance
- Finalize SDTM deliverables
- Generate SDTM datasets
- Manage clinical trial programming tasks
- Optimize processes
- Prepare ADRG
- Prepare SDRG
- Prepare annotated CRFs
- Prepare mock TFLs
- Program ADaM datasets
- Share best practices
- Support change management
- Support clinical study reports
- Support development safety update reports
- Support investigator brochures
- Support periodic safety update reports
- Support public disclosure deliverables
- Support risk management plans
- Support trial execution
- Train colleagues on statistical computing environments
Perks/Benefits
Skills/Tech-stack
ADaM | Annotated CRF | CRF | Clinical data | Clinical data management | Clinical study | Clinical study reports | DSUR | Data Flow | Data Flow Plan | Data Management | Data models | Define-XML | ECRF | GCP | GDP | GPP | Investigator Brochure | PSUR | R | Regulatory Standards | Risk Management | Risk Management Plan | SAS | SDTM
Education
Bachelor of Engineering | Bachelor of Science | Master of Science
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