Dr Gabriella Kocsis-Fodor
- Clinical Biomarker/Biospecimen Operations Manager
- Harwell, Oxfordshire, UK
Personal Summary
I am a Clinical Biomarker/Biospecimen Operations Manager with over a decade of experience in sponsor/CRO settings. My background combines lab-based scientific training with pre-clinical and clinical operations delivery. I have a strong track record in managing global matrix teams across various regions, focusing on oncology and cardiovascular trials. My expertise includes central-lab set-up, vendor selection, clinical performance KPIs, and ensuring inspection-ready documentation. I am adept at aligning budgets, timelines, risks, and quality to deliver high-quality biomarker data on time.
Skills
- Clinical research team leadership: clear communicator, mentoring, task assignment, and performance management
- Operational oversight of biospecimen management, sample logistics (sample/data flow), and clinical trial support
- Regulatory compliance: GCP, ICH Guidelines, SOPs, FDA, EU-CTR
- Audit & inspection readiness: CAPA implementation, trend analysis, gap assessments
- Resource and budget management: study-level financial oversight, cost optimisation
- Cross-functional stakeholder engagement: KOLs, PIs, site staff, Medical Affairs, and Commercial teams
- Presenting training and development programs for clinical research personnel
- Strong stakeholder influence
- Critical reasoning and pragmatic problem-solving
- Digital workflow integration: eCRFs, operational tracking, performance analytics
- HA query support
Licenses and certifications
- PPL NO.: SAB: 1551, 2019, Covance CRS Ltd., UK
- PIL NO.: ENV/19/052, 2019, Covance CRS Ltd., UK
- Study Director Training, 2018, Envigo CRS Ltd., UK
Awards and achievements
- Hit FPFV milestone earlier than planned under my support in 2 clinical trials (Phase 2 & 3 - IVDR compliance - CE marked kits and assays)
- Assured earlier completeness of study sample (LPLV) / result (WOC issues) reconciliation supporting fDBL in 2 clinical trials (Phase 3 - 10 years)
- Initiated a new tracking tool for sample reconciliation, which supported the sponsor’s priority giga trial (Phase 3 - 8300+ patients) iDBL and analysis
- Finalised 5 QA’d reports a couple of weeks earlier than usual, due to the deep understanding of QA systems and workflow
- Organised new Lab Set-up till readiness
- Designed, & implemented a Lab transfer between 2 distant locations and validated and set initiative goals to improve the transferred assays
Work Experience
Q4 2025 set-up for consultancy across clinical ops, GxP quality and biospecimen governance: vendor oversight, TMF QC, kit build reviews, data reconciliation, KPI dashboards, and inspection readiness.
Providing strategic and operational leadership for all biospecimen aspects within clinical trials, from protocol input to study close-out. This includes owning study-level biomarker/ancillary sample plans and lab manuals, providing protocol/ICF input for biomarker collections, blood volume alignment and ethics/regulatory readiness. Liaising with internal stakeholders, trial data scientists, vendors, and laboratories. Setting up central-lab operations, coordinating kit build and sample/accountability workflows; establishing data transfer specs and QC with Data Management; driving eTMF readiness. Supporting site training on technical biospecimen procedures and CDx process; fielded biospecimen-related queries and coordinated responses with cross-functional teams. Driving reconciliation tools, accelerating iDBL/fDBL on priority Phase 3 studies: supporting inspection-ready documentation and GCP compliance. Helping Central Lab to translate protocols into fit-for-purpose databases and SOWs; supporting feasibility leading, and supply forecasting. Managing lab and vendor relationships, reviewing proposals, LSAs and budgets, and ensuring adherence to SOPs and best practices, while escalating risks when needed.
Directing GLP studies per ICH S7A/S7B and UK GLP; cross-functional vendor/lab collaboration to deliver to time/quality. During QA secondment auditing DFA/Safety Pharmacology/BBC reports; strengthening data integrity and report quality. Consulting with sponsors to optimise design choices, clarifying risk and budget impacts. Providing training and mentorship for new colleagues in a supportive environment. Monitoring multiple databases to track and maintain company inventory.
Participating in oncology and cardiovascular research programs, managing laboratory operations and mentoring 13+ students. Authoring or co-authoring over 60 peer-reviewed publications across oncology, antiviral, renal, metabolic, cardiovascular, and colloid chemistry fields.