Sonika Kumari
Mumbai, India
Summary
Innovative thinker with a passion for research, clinical data management, and creative problem-solving. Skilled in translating complex data into actionable insights, ensuring regulatory compliance, and driving efficient workflows. Enthusiastic about blending creativity with analytical precision to deliver impactful results.
Professional Experience
Clinical Data Management Associate
Biotecknika | Dec 2025 – April 2025
- Certified in Clinical Data Management, specializing in Caster EDC, GCP, ICH, and FDA regulations.
- Managed research regulatory compliance, clinical trials, and data analysis.
- Proficient in Veeva Vault for secure data handling and documentation.
Senior Technical Coordinator
Water Mass System Pvt. Ltd., Mumbai | Dec 2025 – Present
- Oversee team schedules, ensuring timely project delivery and operational efficiency.
- Support sales and technical teams by streamlining workflows and maintaining accurate records.
- Coordinate sales meetings, training sessions, and corporate events.
- Enhance customer satisfaction through effective issue resolution and strategic engagement.
QA Associate & Research Analyst
Harshvardhan Laboratories, Pithampur | May 2022 – Dec 2022
- Led quality assurance initiatives, ensuring compliance with GMP and SOPs.
- Conducted internal audits and regulatory reviews for production and R&D.
- Collaborated on formulation development, process validation, and batch record maintenance.
- Experience working with ERP, SAP, and track-wise systems.
Project Associate (Research & Development)
Indian Institute of Technology (IIT) Roorkee | 2019 – 2021
- Investigated bacterial degradation techniques using advanced lab methodologies.
- Gained hands-on experience with protein isolation, purification, and SDS-PAGE.
Education
Master of Technology (M.Tech) | 2017
Rajiv Gandhi Proudyogiki Vishwavidyalaya (RGPV), Bhopal – 7.92 CGPA
Bachelor of Technology (B.Tech) | 2014
Jayoti Vidyapeeth Women’s University, Jaipur – 76.8%
Key Skills
- Clinical Data Management & Research Analysis
- Regulatory Compliance (ICH, FDA, GCP)
- Data Visualization & Reporting
- Quality Assurance & Process Validation
- Technical Coordination & Team Management
- Microbial Isolation & Protein Purification
- Bioinformatics (NCBI, BLAST, Clustal W)
- ERP, SAP, Track-wise System Proficiency
Publications & Research Contributions
- “Epigenetic Modification Through Acetylation in BDNF Gene & Potential New Treatment Targets in Type II Diabetic Retinopathy” – IJIRSET
- “Scrutinizing the Proclamation of BDNF Gene in Retinal Tissue Lacking Epithelial Layer in Type 2 Diabetic Retinopathy” – ResearchGate
- Additional research papers on supervillin, microRNA modifications, and epigenetic analysis.
Skills
- Clinical Data Management
- Research Analysis
- Regulatory Compliance
- Data Visualization
- Quality Assurance
- Process Validation
- Technical Coordination
- Team Management
- Microbial Isolation
- Protein Purification
- Bioinformatics
- ERP
- SAP
- Track-wise System
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Cover Letter:
Certainly! Please provide the data that needs redacting.
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