Sudesh Kapse
Pune
Summary
Oriented Clinical Data Management (CDM) professional with strong hands-on experience in medical chart abstraction, source data verification, and discrepancy management. Proven track record of auditing complex psychiatric progress notes, diagnostic reports, and adverse event narratives against study protocols and Data Validation Plans (DVP). Skilled in cross-referencing unstructured physician notes with EHR systems to ensure audit trail accuracy, resolve query discrepancies with site staff, and uphold strict compliance with ICH-GCP and HIPAA guidelines
Overview
1
1
Certification
1
1
year of professional experience
Work History
Clinical Record Executive
Tech Care medical services
Pune
05.2025 - Current
- Reviewed patient charts, psychiatric progress notes, and diagnostic records against study guidelines and data validation plans to catch missing or conflicting information.
- Checked clinical files and adverse event (AE) reports, reviewing patient narratives and psychiatric terms to make sure events and diagnoses were coded and documented accurately.
- Identified dosing errors, unconfirmed diagnoses, and therapy mismatches; flagged issues and followed up directly with clinical staff to get discrepancies resolved.
- Cross-checked unstructured physician notes and consultation files against EHR system entries to catch documentation gaps and maintain accurate clinical audit trails
- Handled all patient data in strict accordance with HIPAA and ICH-GCP rules, and presented data handling and privacy workflows directly to external auditors.
Education
Post-Graduation Diploma in Clinical Research -
Jehangir Centre For Learning (JCL)
01-2025
Bachelor of Science - Pharmacy
Dattakala College of Pharmacy
Bhigwan06-2024
Skills
- ConsilX Digital
- Electronic Health Record (EHR) Systems
- ICH Guideline
- Good Clinical Practice
- Microsoft Office (Excel, Word)
- VLOOKUP / XLOOKUP
- Clinical Research
Projects
Preperation of Incense Dhoop from waste Flower Tagets Erecta and Aegle Marmelos Leaves.
Languages
- English, Professional Working Proficiency
- Marathi, Full Professional Proficiency
- Hindi, Full Professional Proficiency
Certification
- Registered pharmacist - PCI
- Clinical Research - Pharmacovigilance - CDM
Timeline
Clinical Record Executive
Tech Care medical services
05.2025 - Current
Post-Graduation Diploma in Clinical Research -
Jehangir Centre For Learning (JCL)
Bachelor of Science - Pharmacy
Dattakala College of Pharmacy