Dr Smruti Ghosh
About Candidate
I am a Subject-Level Data Reviewer and medical data professional with six months at IQVIA and 2.5 years of prior hospital-based clinical experience. In my current post as Associate Medical Data Review Manager at IQVIA, I support a multinational Phase III study where I:
Draft and execute Data Review Plans and Risk Assessment Categorization Tools, ensuring audit-ready data locks ahead of schedule.
Build targeted SAS / SQL edit-checks and reconcile Serious Adverse Events and MedDRA coding with safety teams, maintaining 100 % consistency before submission.
Review study metrics in Spotfire and drive prompt query resolution, sustaining >98 % data accuracy.
Operate exclusively in Medidata Rave for all EDC activities, giving me deep hands-on expertise with its SDV, query, and export functions.
My 2.5 years in tertiary hospitals refined my clinical judgment and documentation rigour: I managed over 100 diabetic in-patients monthly at AIG Hospitals, improving EHR completeness and SAE reporting, and rotated through critical-care units at Max Hospital, reducing transcription errors via standardised templates. These experiences translate directly to accurate medical-necessity reviews and fair, compliant claim adjudication.
What I offer your team
Focused expertise: Medidata Rave, SAS, SQL, Spotfire—no “learning curve” on core systems.
Regulatory compliance: GCP, ICH-E6, 21 CFR Part 11 familiarity ensures inspection-ready deliverables.
Clinical insight: MBBS foundation supports nuanced review of diagnoses, procedures, and ICD-10 coding.
Immediate availability: Passport and visit-visa readiness enable a quick move to Dubai.
I am enthusiastic about contributing to Dubai’s vision for high-quality, interoperable health data and would welcome the opportunity to discuss how my background can support companies in accelerating clean data locks and accurate, fraud-free claims processing.
Thank you for your consideration.
Warm regards,
Dr Smruti Shibshankar Ghosh, MBBS
Willing to Relocate to UAE | Dependent visa – under process
Location
Education
Work & Experience
Led SLDR for five Phase III studies (rare disease and endocrinology) covering more than 2,800 subjects at 40 sites across the United States, Europe and MENA, sustaining over 98% data accuracy.- Authored Data Review Plans and Risk Assessment Categorization Tools with statisticians, reducing critical data findings by 35%.- Developed 15 custom edit checks and medical data listings (SAS, SQL, JMP), cutting manual queries by 40% and moving the interim database lock up by three weeks.- Reconciled Serious Adverse Events and MedDRA coding issues with safety teams, achieving 100% consistency before submission.- Integrated vendor data (central labs, ECG, ePRO) and built discrepancy trackers that shortened issue resolution from seven to three days.- Chaired weekly cross functional data meetings, documented corrective actions and closed all within five business days.- Prepared data clean up outputs for CSR and eCTD modules, enabling FDA and EMA inspections with zero major findings in 2025.- Mentored four junior reviewers on GCP compliance, AE coding and query best practices, reducing onboarding time by 25%.- Launched real time KPI dashboards in Spotfire with global programmers, giving sponsors instant study visibility.- Received the IQVIA Quality Excellence Award (Q2 2025) for first time right data submissions.
Managed care for over 100 diabetic inpatients each month, ensuring protocol aligned EHR entries and prompt SAE reporting.- Delivered data quality workshops that improved record completeness by 20%.- Coordinated a Phase IV diabetes registry with the CRO on CRF design and site readiness.
Rotated through Internal Medicine, Cardiac ICU, Neurology and Rheumatology; validated EHR and reduced transcription errors.- Created standard admission templates, lowering incomplete charts by 25%.- Supported infection control audits through data extraction and trend analysis.