Sweety Nikhitha Koppala

• Led end-to-end deployment of digital health systems, including EHR
and telemedicine platforms, optimizing patient recruitment
workflows and reducing enrollment times by 15%.
• Ensured documentation accuracy and compliance with GMP/GLP
guidelines across digital health and data management systems.
Supported QA audits and prepared compliance reports to
maintain high-quality standards.
• Collaborated with clinical, regulatory, and QC teams to ensure data
integrity and
documentation completeness. cnducted quality checks on datasets
and supported risk assessments for system validation.
• Collaborated with clinical teams to identify and target patient
populations for clinical trials, ensuring compliance with ethical
guidelines and improving recruitment efficiency.
• Implemented KPI tracking and performance dashboards to monitor
recruitment metrics, identifying areas for process improvement and
optimizing resource allocation.
• Trained healthcare professionals and research staff on digital
health tools, improving recruitment processes and data
management.
• Supported risk assessments and corrective actions to maintain
patient safety and regulatory compliance during trial
recruitment.

• Managed complex claims and billing processes, improving
operational efficiency and ensuring timely recruitment of
participants for clinical trials by reducing administrative barriers.
• Monitored data accuracy and compliance with healthcare
documentation standards. Applied quality control principles to
ensure completeness and reliability of records.
• Identified and implemented process improvement initiatives to
enhance operational efficiency. Supported audit readiness through
detailed documentation and reporting.
• Worked closely with clinical teams to ensure eligibility verification
and participant documentation were accurate and up-to-date,
supporting smooth trial recruitment.
• Conducted process optimization initiatives, reducing claim
backlogs by 30%, which indirectly improved patient onboarding
timelines for trials.
• Developed training materials for new hires, fostering greater
understanding of clinical trial procedures and patient engagement
strategies.

• Assisted in patient recruitment and enrollment for clinical trials,
conducting eligibility assessments and ensuring all regulatory
documents were completed.
• Conducted analytical testing of trial formulations and recorded
results under GMP- compliant procedures. Maintained laboratory
logs, calibration records, and ensured sample traceability.
• Supported QA and R&D teams in performing quality reviews and
data analysis.Assisted with in-process quality checks, documentation
verification, and sample preparation.
• Participated in developing ibuprofen effervescent tablet
formulations to improve bioavailability and stability. Led the informed consent process and communicated trial
expectations, fostering positive relationships with participants.
• Supervised research staff, ensuring consistent application of study
protocols and patient safety standards.
• Developed and optimized data-gathering processes, increasing
trial accuracy and reducing recruitment delays.