Sruthi Lekha

Contributed to the successful management of clinical trial data for the AbbVie Immunology Project. Focused on data accuracy, regulatory compliance, and ensuring timely completion of critical project phases. Leveraged strong technical and analytical skills to enhance data quality and streamline reporting.

• Conducts daily data reviews using eCRF and Medidata RAVE , addressing discrepancies and ensuring database integrity. Maintains a consistent approach to resolving unreviewed data within project timelines.
• Leads data reconciliation efforts in Immunology trials, utilizing Medidata RAVE and Edit Check Engine (ECE) to reduce data inconsistencies by 25% , securing data lock within set deadlines.
• Implements User Acceptance Testing (UAT) protocols to validate data entry screens and enhances training for site staff, reducing query volume by 20% and improving overall data accuracy.
• Completes Lab Reconciliation and SAE Reconciliation tasks ahead of deadlines, ensuring clean databases with a 100% completion rate before data freezes.
• Designs and optimizes Case Report Forms (CRFs) , improving data collection and validation processes within the Immunology therapeutic area, resulting in cleaner data flow.
• Oversees edit check reviews using ECE , ensuring data quality standards are met, leading to a noticeable decrease in data errors and more efficient data processing.
• Ensures compliance with ICH-GCP , CDASH/CDISC , and FDA guidelines during critical trial phases like data freeze and database lock , contributing to successful trial completions.
• Utilizes Microsoft Excel and advanced formulas like VLOOKUP for data analysis, generating reports that drive decision-making for project managers and stakeholders.
• Adheres to MedDRA and WHO coding standards , ensuring consistent data classification that supports accurate clinical data analysis and reporting.
• Coordinates daily clinical data reports to keep project teams informed, supporting smooth operations and meeting project timelines.

Supported pharmaceutical care and safety while collaborating with specialists to ensure compliance with medical standards, particularly during COVID-19 pandemic.

• Conducted thorough medication therapy management, providing recommendations and counselling 50+ patients weekly on safe medication use.
• Reduced medication errors by reviewing prescriptions for accuracy, drug interactions, and therapeutic duplications, improving patient safety.
• Led efforts to implement new safety protocols during COVID-19 pandemic, ensuring continuous pharmacy operations for over 12 months.
• Collaborated with gynecologists, surgeons, and physicians to deliver personalized treatment plans, enhancing overall patient care.

• Monitoring prescriptions for drug interactions, medication errors, and adverse drug reactions
• Minimizing risk of treatment-induced adverse events, familiar with patient counseling
• Providing drug information and dosage adjustments
• Analyzing patient case sheets and making case reports
• Helping in improving medication adherence in chronic disease patients during research work
• Filling yellow forms for ADR and reporting it to Uppsala monitoring center.
• Conducted comprehensive medication reconciliation reviews during transitions of care to reduce risk of adverse drug events.
• Conducted comprehensive medication reconciliation reviews during transitions of care to reduce risk of adverse drug events.