
Isabella Boccuni, Ph.D.
Undergraduate Researcher

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About me
Clinical Data Manager at OPIS ǀ Medical Biotechnology ǀ Neuroscience ǀ Mini-MBA
Education

Sapienza Università di Roma
2017 - 2019Master's degree Neurobiology 110/110 with honor• Attained comprehensive understanding of brain function, spanning from development to neuroanatomy, neurophysiology, and molecular aspects of neuronal signaling and disease.• Demonstrated academic excellence through achieving the highest grades in all 13 exams completed in the first year.• Developed science communication and team management skills by presenting seminars leading class group projects, including a poster presentation in an Italian-French cultural exchange.

Missione CRA
2024 - 2024"Missione CRA" - 50 hours Clinical Research training course as per the Ministerial Decree 15.11.2011Main Topics are Methodology and Regulation of clinical trials; Good Clinical Practice (ICH-GCP);Standards for Good Manufacturing Practice (GMP); Pharmacovigilance; Quality Systems and Quality Assurance (QA); Focus on Phase 1 Quality; Tasks of Monitors referred to paragraph 5.18 of Annex 1 to the Ministerial Decree July 15, 1997 (including Pre-Study Visit, Site Initiation Visit, Site Monitoring Visit and Close Out Visit); Tasks of Clinical Research Coordinators; Focus on Regulation (EU) N°… Show more Main Topics are Methodology and Regulation of clinical trials; Good Clinical Practice (ICH-GCP);Standards for Good Manufacturing Practice (GMP); Pharmacovigilance; Quality Systems and Quality Assurance (QA); Focus on Phase 1 Quality; Tasks of Monitors referred to paragraph 5.18 of Annex 1 to the Ministerial Decree July 15, 1997 (including Pre-Study Visit, Site Initiation Visit, Site Monitoring Visit and Close Out Visit); Tasks of Clinical Research Coordinators; Focus on Regulation (EU) N° 536/2014; Workshop on Site Selection, Pre-Study Visit, Essential Documents, Drug Accountability; Site visits simulation (PSV, SIV, SMV and COV). Show less
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Ruprecht-Karls-Universität Heidelberg (Heidelberg University)
2020 - 2023Doctor of Philosophy - PhD Neurobiology and Neurosciences Magna cum laudeAs part of the doctoral program at Interdisciplinary Center for Neurosciences, I investigated the mechanisms of retinal degeneration linked to Multiple Sclerosis in collaboration with three different laboratories and I acquired expertise in the following:• Project and time management, demonstrated by meeting research goals within a 4-year timeframe.• Critical thinking and problem-solving ability in stressful experimental settings.• Networking and scientific writing and… Show more As part of the doctoral program at Interdisciplinary Center for Neurosciences, I investigated the mechanisms of retinal degeneration linked to Multiple Sclerosis in collaboration with three different laboratories and I acquired expertise in the following:• Project and time management, demonstrated by meeting research goals within a 4-year timeframe.• Critical thinking and problem-solving ability in stressful experimental settings.• Networking and scientific writing and communication, as shown by 2 peer-reviewed first author publications.• Professional and technical skills, including expertise in molecular biology techniques, in vitro cell culture, ex vivo electrophysiology, in vivo animal work, imaging and data analysis using programming and data visualization softwares. Show less
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International Business Management Institute (IBMI)
2024 - 2024Mini-MBA, Business ManagementA condensed version of the traditional MBA program (20 hours), this Mini-MBA provided a foundational understanding of key business concepts and management principles focusing on core topics like Finance & Accounting, Marketing & Communication, Strategy & Operations, Leadership & Negotiation, International Business and Human Resources Management.
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University of Naples Federico II (Università degli Studi di Napoli Federico II)
2014 - 2017Bachelor's degree Biotechnology for Health 110/110 with honor• In-depth knowledge of molecular and cellular biology, biochemistry, physics, and techniques for studying proteins and nucleic acids.• Specialized in the "medical curriculum," focusing on laboratory experimental applications, research in human physiopathology, diagnostics, and development of new therapeutic techniques in applied medical sciences.
Experience

University of Eastern Finland
Feb 2017 - Jun 2017Undergraduate ResearcherAs an Erasmus+ Traineeship student at the A.I. Virtanen Institute under the supervision of Katja Kanninen, I conducted research on Alzheimer’s disease. The project focused on investigating mitochondrial activity in astrocytes, particularly exploring the impaired mitochondrial turnover mechanism associated with neurodegenerative diseases like Alzheimer's as described in 2 peer-reviewed scientific publications.

Ruprecht-Karls-Universität Heidelberg
Oct 2018 - Oct 2019Graduate ResearcherI took the initiative to contact the laboratory of Ricarda Diem for an internship, where I investigated the role of calcium binding proteins in subtype-specific vulnerability to degeneration in a Multiple Sclerosis disease model. I choose this laboratory especially because of their connection with the Neurology clinic and involvement in clinical trials.

Heidelberg University
Jan 2020 - Oct 2023Doctoral ResearcherAs part of the doctoral program at Interdisciplinary Center for Neurosciences, I investigated the mechanisms of retinal degeneration linked to Multiple Sclerosis in collaboration with three different laboratories and I acquired expertise in the following:• Project and time management, demonstrated by meeting research goals within a 4-year timeframe.• Critical thinking and problem-solving ability in stressful experimental settings.• Networking and scientific writing and communication, as shown by 2 peer-reviewed first author publications.• Professional and technical skills, including expertise in molecular biology techniques, in vitro cell culture, ex vivo electrophysiology, in vivo animal work, imaging and data analysis using programming and data visualization softwares. Show less

OPIS
Oct 2024 - now• Manage clinical data in compliance with CDISC standards, regulatory guidelines, and SOPs.• Design, validate, and maintain CRFs and clinical databases.• Perform data cleaning, SAE reconciliation, and medical coding using standardized dictionaries.• Oversee database changes and ensure rigorous quality controls.• Prepare and archive comprehensive data management documentation.• Collaborate with sponsors, PMs and CRAs to meet project milestones and KPIs.• Ensure timely deliverables through effective activity tracking and milestone management.• Stay updated with continuous training on study-specific and organizational procedures.• Maintain accurate records of billable and non-billable time in tracking systems. Show less • Interact with the Business Development Manager to gather information on client projects.• Work with the Proposal Manager to obtain detailed information on project estimates and clinical study assumptions.• Research information to support proposal requests, including study-related bibliography or database references.• Prepare comprehensive documentation tailored to client requirements, highlighting clinical trial services and relevant expertise.• Create a company profile, as well as profiles for Therapeutic Areas and Specific Indications.• Collaborate with the Marketing Manager to assist in developing graphics, iconography, and similar materials. Show less
Clinical Data Manager
Nov 2024 - nowScientific Proposal Writer Intern
Oct 2024 - Nov 2024
Licenses & Certifications

Effective Communication of Science
SeyensNov 2020- View certificate

Data Management for Clinical Research
Vanderbilt UniversitySept 2024 - View certificate

Project Management Foundations
LinkedInMar 2024 
Project Management in Pharma and Biotech
Boehringer IngelheimMay 2022
Managing Industrial Quality Projects
Boehringer IngelheimDec 2020
Computer System Validation in Clinical Research
FormazioneNelFarmaceutico.comAug 2024- View certificate

Online ICH-GCP Training
GCP CentralApr 2024 
Design and Interpretation of Clinical Trials
The Johns Hopkins UniversityApr 2022
The Expert Patient in Clinical Research
FormazioneNelFarmaceutico.comAug 2024
Writing and Publishing a Scientific Paper in the Natural and Life Sciences
CofactorMar 2021
Volunteer Experience
Executive
Issued by Deutsche Neurowissenschaften-Olympiade on Mar 2021
Associated with Isabella Boccuni, Ph.D.
Languages
- itItalian
- enEnglish
- geGerman
- spSpanish
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