Shagufta Nazir – The Rising Star in Clinical Data Management You Need to Know!

SHAGUFTA NAZIR

PROFESSIONAL SUMMARY
Biotechnology graduate pursuing a Clinical Data Management (CDM) certification, with a strong interest in the Senior Research Data Analyst role. Passionate about data analysis, statistical modeling, and clinical research, with a growing expertise in EDC, CTMS, and eTMF systems. Eager to apply analytical skills and biotech knowledge to optimize data-driven research and clinical workflows while ensuring compliance with industry standards.

EDUCATION

• MSC BIOTECHNOLOGY, AMITY UNIVERSITY, KOLKATA (2022-2024)
  CGPA- [hidden] (Silver Medalist)
• BSC. ZOOLOGY (Hons), CALCUTTA UNIVERSITY, KOLKATA (2019-2022)
  [hidden]

EXPERIENCE

• Biotechnika: Clinical Data Management Training | (3-month Certification Course) (Pursuing)
  Good understanding of regulatory framework like ICH GCP and GDPR. Data standard such as CDASH and SDTM along with tools like EDC system and CDMS, focusing on data integrity and quality metrics. Specialized training on Veeva Vault functionalities, including CRF design, query management data accuracy, automation and compliance monitoring.

INTERNSHIP PROJECT

• Research Intern | Team Lead
  [Amity University], [Kolkata] | [2023]
  • Led a team for the project “Nanoparticle-Based Novel Delivery of Next-Generation Anti-TB Drugs”.
  • Conducted data collection, analysis, and validation while ensuring compliance with research protocols.
  • Documented findings, prepared research reports, and ensured adherence to data management standards.
• Dissertation Researcher
  [Amity University], [Kolkata] | [2024]
  • Investigated the probiotic potential of Lactobacillus isolated from buffalo milk.
  • Designed and executed experiments to evaluate bacterial inhibition properties.
  • Maintained and validated experimental data records for regulatory compliance.

SKILLS

• Clinical Site Monitoring & Off-Site Visits
• Study Protocol Compliance & Regulatory Guidelines
• Good Clinical Practice (GCP), ICH
• EDC, SDTM, CTMS
• Clinical Trial Documentation & Report Submission
• Audit Preparation & Compliance Monitoring
• Business Requirement Analysis
• Data Collection, Analysis, & Interpretation
• Strong Communication & Team Leadership

ACHIEVEMENTS

• Silver Medalist in MSC BIOTECHNOLOGY from (Amity University Kolkata)
• Successfully led a research team and managed end-to-end data collection and analysis

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