Open to opportunities

Mireia Masot Gatius

@mireiamasotgatius

Phase I Clinical Trials Data Manager at VHIO, managing clinical trial data and supporting the development and safety of new medicines.

Spain

Message

What I'm looking for

I’m looking to contribute to the development and safety of new medicines through a new professional project that helps me grow, make use of my strengths, and broaden my career.

At VHIO, I manage and maintain Phase I clinical trial data, resolve queries, and track adverse events and concomitant medication. I also coordinate monitoring visits, audits, and inspections, and support investigators with clinical platforms and databases.

At Laboratorios Menarini, S.A., I managed pharmacovigilance for clinical trials, including adverse event evaluation, safety signal detection, and regulatory reporting. My research training included a project on CAR-T NKG2D immunotherapy for neuroblastoma and laboratory work in cancer research.

Experience

Work history, roles, and key accomplishments

Current

Phase I Clinical Trials Data Manager

Current

VHIO

Nov 2023 - Present (3 years)

Managed and maintained Phase I clinical trial data using CRFs, including procedure and visit registration, query resolution, and follow-up of AEs/SAEs and concomitant medication. Coordinated monitoring visits, audits, and inspections, and supported investigators with clinical platforms and databases.

Clinical Data Management CRF Query Resolution AE SAE Reporting Clinical Trials Regulatory Compliance Database Management

Junior Study Drug Safety Technician

Laboratorios Menarini, S.A.

Nov 2022 - Nov 2023 (1 year)

Managed pharmacovigilance in clinical trials, including preparation and review of safety documentation (protocol, IB, CSR, eCRF, Safety Management Plan), collection and evaluation of adverse events, patient safety monitoring, signal detection, and regulatory reporting (DSUR, SUSARs). Validated data and resolved queries in compliance with international pharmacovigilance regulations.

Pharmacovigilance Clinical Trials Adverse Event Reporting Signal Detection Regulatory Reporting DSURs SUSARs Data Validation

Research Intern in Translational Pediatric Cancer

Instituto de Investigación Hospital Universitario La Paz

Feb 2022 - Jun 2022 (4 months)

Developed a final degree project on new strategies combining NKG2D CAR-T immunotherapy and epigenetic pharmacological regulation of its ligands for high-risk neuroblastoma treatment. Performed laboratory techniques including cell culture, 3D models, flow cytometry, CAR-T generation, MTT viability assays, and Western blot.

Cell Culture 3D Cell Culture Flow Cytometry CAR T Therapies MTT Assay Western Blot Immunotherapy Epigenetics

Research Intern in Tumor Resistance and Microenvironment

Institut Català d'Oncologia (ICO)

Jul 2021 - Aug 2021 (1 month)

Studied the influence of carcinoma-associated fibroblasts (CAFs) on tumorigenesis and treatment resistance in pancreatic cancer. Performed laboratory techniques including cell culture, RNA extraction, qRT-PCR, protein extraction, Western blot, and immunohistochemistry of pancreatic tumors from orthoxenografts.

Cell Culture RNA Extraction Quantitative Real Time PCR Protein Extraction Western Blot Immunohistochemistry Cancer Research

Research Intern in Oncogenic and Developmental Signaling

IRB Lleida

Sep 2020 - Sep 2020 (0 months)

Genotyped Spry1 and Spry2 genes involved in genitourinary tract development using PCR and electrophoresis. Performed Western blot on protein extracts from neonatal KO/WT mouse tails.

PCR Electrophoresis Western Blot Genotyping Methods Molecular Biology