Clinical Research · Data · Vienna

Judith
Lavric

Clinical Research Associate transitioning into Clinical Data Management — combining 3+ years of hands-on GCP experience with growing expertise in data analysis and digital health systems.

View Experience Get in Touch
3+
Years in Clinical Research & Documentation
4
Clinical & Hospital Settings
100%
Audit & Inspection Readiness Record
About

Where Clinical Expertise
Meets Data

I am a detail-oriented healthcare professional with a background spanning clinical documentation, source data verification (SDV), regulatory compliance, and site coordination. My career has been built in high-stakes hospital environments where accuracy is non-negotiable.

Currently completing a BSc in Biotechnology (Sept 2026), I am actively transitioning into the intersection of clinical research and data — building skills in Python, SQL, and clinical data systems to complement my deep understanding of GCP workflows.

I am fluent in German (C2) and English (C1), remote- and travel-ready across Europe, and available immediately for CRA or Clinical Data roles.

ICH-GCP E6 R2/R3 ISO 14155 MDR EU 2017/745 FDA 21 CFR Part 11 GDPR Veeva Vault SAP / ELGA
Email [email protected]
Phone +43 699 1800 9026
Location Vienna, Austria
Availability Immediately available
Mobility Remote & travel-ready / Europe
Languages German C2 · English C1
Experience

Professional Timeline

Feb 2024
— Present
Clinical Research & Medical Documentation Assistant
Hospital of the Brothers of Mercy — Vienna, Austria
  • Performed source data verification (SDV) and QC reviews of patient records and anesthesia documentation, ensuring compliance with ICH-GCP, ISO 14155, and internal SOPs.
  • Executed structured data entry into SAP and ELGA (EHR) systems, mirroring EDC/eCRF workflows with focus on data integrity, traceability, and query resolution.
  • Maintained essential clinical documents within eTMF-equivalent archiving systems, ensuring 100% inspection and audit readiness.
  • Identified documentation discrepancies and protocol deviations; escalated findings in line with CRA-style monitoring workflows.
  • Ensured full GDPR-compliant handling of sensitive patient health information.
Oct 2023
— Feb 2024
Laboratory Assistant & Clinical Data Associate
Allergy Outpatient Clinic — Vienna, Austria
  • Processed, centrifuged, and documented biological samples (blood, serum) per laboratory SOPs, maintaining chain-of-custody standards consistent with clinical trial sample management.
  • Transcribed and verified laboratory results for clinical reporting, applying QC data entry checks analogous to EDC source data verification.
  • Maintained audit-ready sample tracking logs and supported preparation for internal quality audits.
Nov 2022
— Sep 2023
Ward Supervisor & Clinical Coordinator — Infectious Diseases
University Medical Center Mainz — Mainz, Germany
  • Coordinated interdisciplinary physician rounds and daily clinical briefings, ensuring procedural compliance and complete, timely documentation.
  • Supervised clinical workflows, delegated tasks, and monitored SOP adherence across a multidisciplinary team — aligned with CRA site-oversight responsibilities.
  • Onboarded and trained new clinical staff on documentation standards and internal procedures.
  • Performed venipuncture and managed related laboratory documentation and sample tracking.
Jun 2022
— Sep 2023
Emergency Medical Staff
University Medical Center Mainz — Mainz, Germany
  • Managed accurate, timely patient record documentation in high-pressure emergency settings, demonstrating composure and prioritization under clinical pressure.
Competencies

Core Skills

🔬
Clinical Research
  • ICH-GCP E6 R2/R3
  • Risk-Based Monitoring (RBM)
  • Site Initiation / Close-Out Visits
  • Source Data Verification (SDV)
  • AE/SAE Documentation
  • Protocol Deviation Management
  • ICF Review & Pharmacovigilance
📋
Regulatory & Compliance
  • ISO 14155 · MDR EU 2017/745
  • FDA 21 CFR Part 11
  • EMA Regulations · GDPR
  • SOP Development & QA/QC
  • Audit & Inspection Readiness
  • CAPA Awareness
  • eTMF / TMF Management
💻
Technical Systems
  • Veeva Vault (eTMF)
  • SAP · ELGA (EHR)
  • EDC / eCRF Platforms
  • CTMS (familiar)
  • MS Office 365
  • Python
  • SQL
Portfolio Project

Data Analysis Work

Clinical Data Analysis · Python
Adverse Events Analysis — Simulated Clinical Trial Dataset

A data analysis project simulating the review and classification of adverse events (AEs) from a Phase II clinical trial dataset. Demonstrates the application of CRA domain knowledge to automate data quality checks, flag severity patterns, and generate summary reports — skills directly applicable to Clinical Data Manager roles.

⚙️ Project in development — combining clinical research expertise with Python & Pandas.

Python Pandas Matplotlib CDISC SDTM concepts AE Classification Data QC
AE SEVERITY DISTRIBUTION (SIMULATED)
Mild
72%
Moderate
20%
Severe
8%
AE RATE BY STUDY WEEK
Week 1–4
34
Week 5–8
22
Week 9–12
12
Education

Academic Background

Medical Specialist Training
Medizinische Fachangestellte (MFA)
Formal clinical training covering patient documentation, laboratory procedures, regulatory compliance, and healthcare workflows in medical settings.
ICH-GCP Certification
Good Clinical Practice · E6 R2/R3
In-depth knowledge of GCP guidelines governing the conduct of clinical trials, including subject protection, data integrity, and audit readiness standards.
Regulatory Frameworks
ISO 14155 · MDR · FDA 21 CFR Part 11
Practical working knowledge of EU and US regulatory requirements for clinical research, medical devices, and electronic record management.