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Mirna Valvano

@mirnavalvano

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Clinical research professional specialized in CRA activities, regulatory compliance, and data analysis.

Italy

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What I'm looking for

I seek CRA or regulatory roles in collaborative, quality-focused teams where I can apply regulatory expertise, TMF/Veeva skills, and data analysis to support compliant, efficient clinical trials.

I am a clinical research professional with extensive experience in CRA operations, regulatory submissions, and TMF/eTMF management, having supported investigator site identification, feasibility assessments, IRB/IEC submissions, and Veeva Vault-based document control. I have contributed to clinical trial support, scientific consultancy, and computational research including miRNA NGS analysis and molecular modelling.

I bring proven skills in inspection readiness, CTMS maintenance, contracts and budgets support, and pharmacovigilance training, combined with strong IT capabilities in Python, Perl, C, and MySQL. I am committed to accurate documentation, quality control, and cross-functional collaboration to ensure compliant, efficient clinical trials.

Experience

Work history, roles, and key accomplishments

In-House Clinical Research Associate

Simbec Orion CRO

Oct 2021 - Oct 2025 (4 years)

Managed site identification, feasibility, regulatory submissions and TMF/eTMF in Veeva Vault, improving inspection readiness and supporting study close-out and CAPA follow-up across clinical trials.

ICH GCP ETMF Veeva CTMS Regulatory Submissions CAPA

Scientific Advisor

CR Pharma / Diagnostica Spire / Puglia Life

Jan 2019 - Dec 2020 (1 year 11 months)

Provided scientific consultancy and prepared scientific documentation for healthcare and diagnostics organizations to support research and product development activities.

Research Collaboration Technical Writing

Clinical Trials Support

CVBF

Jan 2016 - Dec 2017 (1 year 11 months)

Supported international clinical trials including eCRF data entry, data management, EC communications, and laboratory sample handling and shipment for the DEEP Project.

Data Management Clinical Trial Management Quality Control

Research Scientist — Bioinformatics

Various (CNR ITB / GARR-X / BIOFORDRUG)

Jan 2012 - Dec 2016 (4 years 11 months)

Conducted digital infrastructure research, microRNA NGS analysis and molecular modelling supporting computational genomics projects and data analysis pipelines.

MicroRNA Computational Genomics Python Perl MySQL