Sushama Pisar
Bengaluru
Summary
A dedicated, organized, and experienced professional with 4+ years of expertise as a Medical Data Reviewer and Transparency/Redaction Analyst. Skilled in analyzing and extracting patient-specific data across clinical trial projects, with a strong understanding of data privacy, transparency, and disclosure requirements.
Overview
4
4
years of professional experience
1
1
Certification
Work History
Senior Medical Reviewer
Omega Healthcare
Bengaluru
09.2021 - Current
- Medical Document Review: Experienced in handling U.S. healthcare medical documents; reviewed project-specific documents in alignment with project SOPs, analyzing and abstracting relevant data with accuracy.
- Real-World Data (RWD/RWE): Hands-on experience working with eCRFs, Real-World Data/Evidence, and oncology-specific EMRs/EHRs including ARIA Manager and EPIC.
- Oncology Expertise: Worked across multiple oncology projects, including Breast Cancer, Prostate Cancer, Chronic Lymphocytic Leukemia (CLL), and Non-Small Cell Lung Cancer (NSCLC).
- Data Abstraction & Eligibility Review: Extracted patient data from oncology EMRs into eCRFs based on project-specific inclusion/exclusion criteria, ensuring all enrolled patients met protocol-defined eligibility requirements.
- Clinical Data Review: Reviewed key patient data such as date of diagnosis, pathology findings, laboratory results, drug-related adverse events (graded by severity), coding dictionaries, data tables, listings, figures, genetic data, and treatment history up to end-of-life.
- Quality Control (QC) & Chart Audit: Performed chart audits and QC checks within EMRs, serving as a Quality Control Analyst to validate data integrity and ensure compliance with project requirements.
- Query Management: Managed, tracked, and resolved data queries to maintain accuracy and completeness of clinical datasets.
- Team Collaboration: Experienced working in fast-paced, adaptable, and collaborative environments, contributing to cross-functional project success.
Transparency/ Redaction Analyst
Omega Healthcare
Bengaluru
07.2024 - Current
- Redaction: Skilled in the redaction of sensitive information in clinical trial documents, including study protocols, statistical analysis plans (SAPs), clinical study reports (CSRs), and patient narratives, ensuring compliance with data privacy regulations (GDPR), and the protection of confidential business information.
- Clinical Trial Disclosure: Hands-on experience with protocol registration on ClinicalTrials.gov with a strong focus on oncology clinical trials.
- Proficient in using the Protocol Registration System (PRS) for timely and compliant clinical trial registration.
- Regulatory Knowledge: Good understanding of global requirements for trial disclosure and transparency (FDAAA 801, EU Clinical Trial Regulation [EU CTR 536/2014], EMA Policy 0070, Health Canada PRCI).
- Strong focus on accuracy, confidentiality, and compliance while working with sensitive patient-level data and study information
Education
Master of Science -
Nagpur University
Nagpur06-2017
Skills
- EMR/EHR, eCRF, Oncology EMR (Onco EMR, Aria Manager, EPIC)
- ICH-GCP, ICMR, CIOMS, CPCSEA guidelines
- Clinical drug development, real-world data/evidence
- Time Management & Multitasking
- Adaptability to Changing Regulatory Environments
- Microsoft Office Suite (Excel, PowerPoint, Word)
Accomplishments
- Maintained a quality score of 99.58%–100% in data abstraction across oncology projects.
- Received four Spot Awards for outstanding performance and consistently exceeding quality expectations
Languages
Marathi
First Language
English
Proficient (C2)
C2
Hindi
Proficient (C2)
C2
Certification
- PGDM in Clinical Research, Clariwell Global Solution (2020–2021)
- EHR Certification Prep for IC Data Curator (2023)
- Good Clinical Practice (GCP) – NIDA Clinical Trials Network
Timeline
Transparency/ Redaction Analyst
Omega Healthcare
07.2024 - Current
Senior Medical Reviewer
Omega Healthcare
09.2021 - Current
Master of Science -
Nagpur University
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