Małgorzata Gracjas
Central Monitoring Lead | RBQM Specialist | Senior CRA
Pewel Mała
Profil zawodowy
Experienced Central Monitoring Lead and Senior CRA with over 10 years of comprehensive clinical trials experience (Phases I–IV), including a proven track record of 2+ years directly leading RBM & RBQM operations at a global level. Deep expertise in data-driven quality management, evaluating Key Risk Indicators (KRIs), and conducting Quality Tolerance Limit (QTL) assessments. Skilled in bridging central risk surveillance with practical site operations to drive inspection readiness and proactive issue mitigation. Currently enhancing expertise through post-graduate studies in Clinical Trial Operations.
Podsumowanie
3
3
Languages
14
14
years of professional experience
Doświadczenie
Senior Clinical Research Associate
ICON Clinical Research
Żywiec, Poland
2026.05 - Current
- Lead the operational execution of Risk-Based Monitoring (RBM) strategies at the site level, translationally applying RBQM principles to regional clinical site management.
- Proactively analyze site performance metrics and risk indicators to identify systemic data trends, potential quality anomalies and high-risk anomalies early.
- Perform on-site and remote monitoring visits in accordance with ICH-GCP and company SOPs.
- Ensure patient safety, protocol compliance, and high-quality clinical data.
- Conduct Source Data Verification (SDV) and Source Data Review (SDR).
- Identify protocol deviations and quality risks, ensuring timely resolution.
- Contribute to CAPA implementation and quality improvement initiatives.
- Cross functional collaboration.
- Train and mentor investigational site personnel and other CRAs.
Central Monitoring Lead - RBM & RBQM
Fortrea
Żywiec, Poland
2024.02 - 2026.04
- Centralized monitoring and proactive risk management workflows for complex, multi-center global clinical trials across various sponsors.
- Owned the execution of monthly data and risk reviews, ensuring alignment with ICH E6(R2)/(R3) and ICH E8(R1).
- Evaluated complex site risk indicators, quality trends and analytical dashboards to trigger targeted data-driven mitigations and prevent critical issues.
- Facilitated cross-functional collaboration with global study teams to establish, monitor and adjust Quality Tolerance Limits (QTLs).
- Joint Data Reviews between Risk Reviews, Medical Reviews and Statistic Reviews.
- Interpreted multi-source clinical data streams (EDC, CTMS, IVRS, eTMF etc.)
- Authored and maintained Study Configuration Plans (CPs), Integrated Quality and Risk Management Plans (IQRMPs) and Central Monitoring Plans (CMPs) tailored to study complexities and sponsor requirements.
- Supervised, mentored and provided operational oversight to team of Central Monitors, ensuring high-quality, timely delivery of monthly risk reviews and consistency in data analysis.
Senior Clinical Research Associate
Fortrea
Żywiec, Poland
2021.10 - 2024.01
Clinical Research Associate II
Fortrea
Żywiec, Poland
2019.06 - 2021.09
Clinical Research Associate I
PRA Health Sciences
Katowice, Poland
2018.08 - 2019.05
Clinical Research Associate
Brillance
Katowice, Poland
2018.04 - 2018.07
Junior Clinical Research Associate | Lead CTA
Brillance
Katowice, Poland
2017.06 - 2018.03
Clinical Trial Administrator | In-house CRA
Brillance
Kraków, Poland
2016.06 - 2017.05
Clinical Data Coordinator II
Synexus
Katowice, Poland
2015.05 - 2016.05
Clinical Data Coordinator I
Synexus
Katowice, Poland
2014.12 - 2015.04
Junior Clinical Data Coordinator
Synexus
Katowice, Poland
2013.12 - 2014.11
Medical Receptionist | Clinical Trials
Synexus
Katowice, Poland
2013.04 - 2013.11
Wykształcenie
Post-Graduate - Clinical Trial Operations: Foundations and Practice
Akademia Leona Koźmińskiego
2026.10 - Current
Bachelor of Arts - Philological Department
Uniwersytet Śląski w Katowicach
Umiejętności
- Analytical thinking
- Risk-based decision making
- Quality-focused mindset
- Open communication
- Leadership
- Strong organizational skills
- Cross-functional collaboration
- Problem Solving
- Continuous improvement
- Attention to detail
- Timeline and milestone management
- Risk-Based Monitoring (RBM)
- Risk-Based Quality Management (RBQM)
- Centralized Monitoring
- Clinical Trial Oversight
- Risk Assessment & Mitigation
- Quality Management Systems
- Clinical Operations
- ICH-GCP / GCP Compliance
- Protocol Compliance
- Data Quality & Data Integrity
- Key Risk Indicators (KRIs)
- Quality Tolerance Limits (QTLs)
- Root Cause Analysis (RCA)
- CAPA Development & Follow-up
- Inspection Readiness
- Site Performance Management
- Remote Monitoring
- Cross-functional Leadership
- Vendor Collaboration
- Clinical Trial Management
- Process Improvement
- Stakeholder Management
- Clinical Systems
- CTMS
- EDC (Medidata Rave, Inform, Oracle, etc)
- ETMF
- IWRS/IRT
- Microsoft Office
- Microsoft Excel (Advanced)
Languages
Polish
Proficient
C2
English
Proficient
C2
Italian
Intermediate
B1
Oś czasu
Post-Graduate - Clinical Trial Operations: Foundations and Practice
Akademia Leona Koźmińskiego
2026.10 - Current
Senior Clinical Research Associate
ICON Clinical Research
2026.05 - Current
Central Monitoring Lead - RBM & RBQM
Fortrea
2024.02 - 2026.04
Senior Clinical Research Associate
Fortrea
2021.10 - 2024.01
Clinical Research Associate II
Fortrea
2019.06 - 2021.09
Clinical Research Associate I
PRA Health Sciences
2018.08 - 2019.05
Clinical Research Associate
Brillance
2018.04 - 2018.07
Junior Clinical Research Associate | Lead CTA
Brillance
2017.06 - 2018.03
Clinical Trial Administrator | In-house CRA
Brillance
2016.06 - 2017.05
Clinical Data Coordinator II
Synexus
2015.05 - 2016.05
Clinical Data Coordinator I
Synexus
2014.12 - 2015.04
Junior Clinical Data Coordinator
Synexus
2013.12 - 2014.11
Medical Receptionist | Clinical Trials
Synexus
2013.04 - 2013.11
Bachelor of Arts - Philological Department
Uniwersytet Śląski w Katowicach