**Sonika Kumari**
New Delhi, India
Intro Summary: Sonika Kumari is a Creative Research & Data Management Specialist with expertise in clinical data management, research analysis, and regulatory compliance. She excels in translating complex data into actionable insights and is skilled in data visualization, technical coordination, and strategic planning. Sonika combines 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 2024**
– 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.
**Junior Research Fellow IIT Roorkee | 2018 – 2019**
– Specialized in biodegradation of aromatic compounds using GC-MS analysis.
– Conducted bacterial isolation, cloning, and protein expression experiments.
**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 (DOI: 10.15680/IJIRSET.[Phone Hidden])
– “Scrutinizing the Proclamation of BDNF Gene in Retinal Tissue Lacking Epithelial Layer in Type 2 Diabetic Retinopathy” – ResearchGate (DOI: 10.13140/RG.2.2.[Phone Hidden])
– Additional research papers on supervillin, microRNA modifications, and epigenetic analysis.
Cover Letter:
I am very much interested in the Research Associate position and can join immediately. I hold a master’s degree specialising in biotechnology and have a solid background in clinical research, data management, and regulatory compliance. I am excited about the opportunity to contribute to your esteemed organisation.
As a Clinical Data Management Associate at fBiotecknika, I have honed my expertise in handling clinical trial data, ensuring adherence to **GCP, ICH, and FDA regulations, and utilising electronic data capture systems like Caster EDC, excel sheet preparation and Veeva Vault. **My experience extends to overseeing research compliance, conducting data analysis, and maintaining secure documentation practices.
In addition to my clinical data management experience, my tenure as a QA Associate and Research Analyst at Harvardhan Laboratories has equipped me with a strong foundation in quality assurance, GMP compliance, and regulatory reviews. Furthermore, **my research background at IIT Roorkee,** which focused on microbial isolation and protein purification, has strengthened my analytical and problem-solving abilities.
I am eager to bring my detail-oriented approach, technical expertise, and passion. I am confident that my experience and skills align well with the requirements of this role. I welcome the opportunity to discuss how my qualifications can benefit your team.
Thank you for your time and consideration. I look forward to hearing from you.
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