Nalini S
Clinical Research
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About
PhD-qualified Biochemist transitioning into Clinical Data Management and Clinical Research with hands-on training in clinical trial processes, eCRF, data validation, and query management. Strong understanding of ICH-GCP guidelines, clinical data review, and regulatory compliance. Experienced in handling clinical datasets, documentation, and supporting study timelines in fast-paced, cross-functional environments.
Experience
Clinical Research Intern at Biotecnika Clinical Research Training Program (2026 – Present)
Clinical Research Intern with hands-on training in clinical trial processes
- Gained theoretical knowledge of eCRF design and clinical data workflows
- Learned principles of data validation checks and edit specifications
- Understood clinical data review processes and data review plans
- Trained in identifying discrepancies and query generation concepts
- Acquired knowledge of clinical data cleaning and database management
- Learned study documentation practices including filing and archiving
- Developed understanding of ICH-GCP guidelines and regulatory requirements
- Conducted clinical data collection, organization, and analysis
- Performed literature review and comparative outcome assessment
Assistant Professor – Biochemistry at The Oxford College of Science, Bangalore (2023 – 2024)
Assistant Professor teaching Biochemistry
Guest Faculty – MSc Biochemistry at Bangalore City University (2019 – 2022)
Guest Faculty for MSc Biochemistry program
- Managed documentation, reporting, and academic coordination
- Guided postgraduate research projects and data interpretation
- Coordinated NAAC documentation and audit processes
- Demonstrated strong skills in data handling, reporting, and compliance
Education
PhD in Biochemistry – Kuvempu University (2013 – 2018)
MSc in Biochemistry – Bangalore University (2010)
BSc in Chemistry, Botany, Microbiology – Bangalore University (2008)
