ANDREA GELECSAK
Dublin
Summary
Clinical operations professional with 8+ years of experience in global clinical trials within pharmaceutical and CRO environments. Expertise in Trial Master File (TMF) governance, vendor oversight, clinical documentation management, and process optimization supporting Phase I–IV clinical studies. Proven track record of ensuring GCP compliance, inspection readiness, and operational excellence through strong stakeholder collaboration.
Personality: Team Player, Agile, Proactive, Curious and Result-Oriented
Overview
10
10
years of professional experience
1
1
Certification
Work History
TMF Oversight Manager – Clinical Operations
Novartis
Dublin
07.2023 - Current
- Lead TMF oversight across a portfolio of global clinical studies ensuring regulatory compliance and document quality.
- Manage and mentor a team of 5 TMF Managers and support TMF governance across clinical programs.
- Implement risk‑based TMF management strategies and mitigation plans to maintain inspection readiness.
- Execute vendor oversight plans and monitor KPIs and service metrics.
- Collaborate with Clinical Operations, Data Management, Regulatory Affairs and QA teams.
- Drive process improvement initiatives to enhance TMF quality and operational efficiency.
Senior Clinical Document Specialist
Novartis
Dublin
01.2022 - 07.2023
- Managed TMF documentation oversight ensuring completeness and compliance with GCP.
- Performed document quality checks and maintained Expected Document Lists (EDL).
- Supported TMF health checks and inspection readiness activities.
Senior Clinical Trial Assistant
Labcorp
Vienna
01.2020 - 01.2022
- Supported global Phase I–IV clinical trials and collaborated with study managers and CRAs.
- Coordinated Investigator Site Files (ISF) and eTMF documentation.
- Performed eTMF quality control reviews and supported study budget tracking.
Project Coordinator – Clinical Study Support
Baxalta
Vienna
01.2018 - 01.2020
- Supported sponsor oversight of clinical trials and collaborated with project managers.
- Reviewed contracts, informed consent forms (ICFs) and site visit reports.
- Managed TMF documentation and compliance activities.
Clinical Support Specialist
Baxalta
Vienna
01.2016 - 01.2018
- Supported clinical project teams with CTA processing and contract amendments.
- Managed vendor communication and invoice processing.
- Investigated and resolved invoice discrepancies.
Education
Postgraduate Degree - Translator in Economic & Social Sciences (English–Hungarian)
János Kodolányi College
BudapestBA - International Studies / International Relations
King Sigismund College
BudapestSkills
- TMF Governance & Oversight
- Clinical Trial Operations
- Vendor Management & Oversight
- GCP & Regulatory Compliance
- Inspection Readiness
- Risk Assessment & Mitigation
- Clinical Documentation Management
- Process Optimization
- Cross‑Functional Stakeholder Management
- Project & Portfolio Coordination
- Quality Control & Audit Preparation
- Budget Tracking & Invoice Management
Websites
Certification
Veeva Vault – Business Administrator Certification
Hobbies and Interests
- Horse Riding
- Sea Swimming
Languages
- English
- German
- Hungarian, Native / C2
- English, Fluent / C2
- German, Advanced / C1
Languages
Hungarian
First Language
English
Proficient
C2
German
Advanced
C1
Timeline
TMF Oversight Manager – Clinical Operations
Novartis
07.2023 - Current
Senior Clinical Document Specialist
Novartis
01.2022 - 07.2023
Senior Clinical Trial Assistant
Labcorp
01.2020 - 01.2022
Project Coordinator – Clinical Study Support
Baxalta
01.2018 - 01.2020
Clinical Support Specialist
Baxalta
01.2016 - 01.2018
Postgraduate Degree - Translator in Economic & Social Sciences (English–Hungarian)
János Kodolányi College
BA - International Studies / International Relations
King Sigismund College