Swati Sharma

• Achieved compliant clinical trial execution through meticulous planning and documentation in accordance with ICH-GCP guidelines.
  Ensured high-quality protocols, ICFs, CRFs, and SOPs through comprehensive review processes.
  Streamlined communication between investigators, sponsors, and site teams, enhancing operational efficiency.
  Delivered successful regulatory submissions, achieving data quality and compliance.

• Oversaw laboratory and clinical research activities adhering to ICH-GCP, NABL, and FDA-aligned regulatory standards.
  Managed human biospecimen processing and documentation, ensuring robust traceability and data integrity.
  Executed molecular and cell-based assays that supported key clinical and translational research initiatives.
  Maintained compliance with SOP-driven workflows to uphold audit readiness and quality assurance.
  Coordinated clinical documentation and sample tracking, collaborating effectively with investigators.

• Conducted biological sample processing including blood and tissue-derived specimens for molecular and biochemical analysis
• Assisted in microscopy-based examination of samples as part of research data validation
• Supported laboratory workflows requiring precision handling at cellular and subcellular levels

Achieved precise clinical diagnostic testing on blood and biological samples, enhancing accuracy in results.
Delivered reliable brightfield microscopy examinations for routine haematological assessments.
Improved efficiency in sample preparation and slide processing for cellular evaluations.