Summary
Overview
Work History
Education
Skills
Accomplishments
Additional Information
Lenguage
Personal Details
References
Timeline
Generic
MARIANEVE QUARTUCCIO

MARIANEVE QUARTUCCIO

Caslano

Summary

I am an accomplished Medical Operations professional with extensive expertise in managing and executing clinical trials, medical projects, and operational logistics. I bring over 8 years of experience in small to mid-size pharmaceutical organizations, leveraging my strong project management skills, regulatory compliance expertise, and proficiency in coordinating cross-functional teams to drive seamless execution of complex initiatives. My ability to manage budgets, stakeholder relationships, and deliver results in dynamic environments positions me as a valuable asset to your team.

Overview

18
18
years of professional experience

Work History

CLINICAL OPERATIONS SPECIALIST

Sintetica SA, Mendrisio San Martino
Ticino
01.2024 - 12.2024
  • Managed clinical studies, ensuring adherence to schedules, budgets, and compliance standards.
  • Coordinated logistics and handled contracts for European medical events.
  • Supervised agency activities to ensure seamless delivery and timely completion of projects.
  • Collaborated with cross-functional teams to track action items and meet project milestones.

Interventional Clinical Trial:

  • Evaluate the safety and e􀀁cacy of the anesthetic intervention during pediatric surgeries. (Phase II, study conducted in multiple sites in Europe).
  • Investigate and compare the clinical e􀀁cacy of using eye drops as a form of anesthesia in pediatric clinical practice. The study seeks to provide evidence for the use of non-invasive anesthetic methods in children, focusing on patient comfort and pain management. (Phase III, study conducted in multiple sites in Europe).

CLINICAL TRIAL ASSOCIATE

CSL Vifor International
Zurich
06.2022 - 10.2023
  • Coordinated operational execution of global clinical trials from initiation to closeo
  • Managed logistics for European conferences and congresses, ensuring seamless execution.
  • Maintained detailed financial tracking and processed invoices aligned with budget requirements.
  • Addressed medical inquiries and collaborated with CROs and investigators.

Interventional Clinical Trial:

  • Chronic kidney disease in pediatric patients undergoing dialysis (Phase I, study conducted at multiple sites in the United Kingdom, Lebanon, and Turkey).
  • Cardiovascular disease in chronic kidney disease in adult subjects (Phase I, study conducted at multiple sites in Europe).
  • Hypercalemia in adult subjects (Phase III, study conducted in multiple sites in China).

Early Patient Access Programme:

  • End Stage Chronic kidney disease in adult patient undergoing in dialysis (program conducted in Europe and USA).

Clinical Coordinator - Samples Management

F. Hoffman La Roche Ltd
Basel
11.2017 - 05.2022
  • Coordinated operations for global clinical trials from initiation to closeout.
  • Managed logistics for European conferences and congresses, ensuring successful execution.
  • Maintained financial records and addressed medical inquiries with compliance standards.

Quality Assurance Specialist

Quotient Ltd
Geneva
01.2017 - 10.2017
  • Regulatory Documentation : Organized and maintained comprehensive archives of test data for raw materials, intermediate stages, and nal products, ensuring alignment with regulatory standards and facilitating compliance with medical and pharmaceutical regulations.
  • Monitored product quality through systematic testing and ensured compliance with regulatory standards for pharmaceutical products.
  • Facilitated internal audits and coordinated with teams to address quality-related issues in trial product manufacturing.

MEDICAL LABORATORY SCIENTIST

Bern
12.2013 - 12.2016
  • Project: Testing of new compounds for cancer treatment on primary human cell.

Biomedical Scientist

Public Health England
London
10.2012 - 11.2013
  • Performing PCR tests on various clinical samples for the detection of bacteria antibiotic resistant and viruses performed with automatic equipment
  • Data entry (patient data); checking and archiving testing documents; delivering testing results; to archive all documentation following procedures in place
  • Asset PCR testing for detection of antibiotic resistance.

RESEARCH ASSISTANT

Imperial London Collage
London
03.2011 - 10.2012
  • Project: Optimization and improving DNA Assembly techniques.

BIOLOGIST

Health and Care National Service
Naples
01.2007 - 05.2011
  • Laboratory Medicine: Day-to-day sample processing and routine tests in haematology, biochemistry, microbiology, toxicology, and reproductive biology.

BIOLOGIST

Salam Centre for Cardiac Surgery Hospital, NGO Emergency
04.2008 - 11.2008
  • Management of Laboratory Medicine and of Blood Bank and Transfusion Centre.

Education

MASTER DEGREE - MEDICAL BIOTECHNOLOGY

University of Study of Naples "Federico II
10.2006

BACHELOR - HEALTH BIOTECHNOLOGY

University of Study of Naples "Federico II
02.2005

Skills

  • Medical Operations Management: Expert in planning, coordinating, and executing medical activities, including advisory boards, roundtables, and local events
  • Regulatory Compliance: Proficient in medical affairs compliance, regulatory submissions, and European pharmaceutical laws
  • Project Management: Skilled in managing contracts, timelines, and budgets to ensure seamless delivery of projects
  • Agency and Stakeholder Engagement: Experience in managing agencies and fostering effective collaboration with internal teams and external stakeholders
  • Technical Proficiency: CTMS, eTMF, Veeva Vault, SharePoint, Microsoft Office Suite, and tools like Zoom, Teams, and Slack
  • Multilingual Communication: Fluent in English; knowledge of Italian and other European languages

Accomplishments

  • GCP Second Level Investigator – Sponsor, accredited by Swiss Clinical Trial Unit - EOC (Ente Ospedaliero Cantonale), Lugano, Switzerland (2023)
  • Orphan Drugs Clinical Trial, Symmetric Pharmaceutical and Biotech Training Courses, Bratislava, Check Republic (2023)
  • ICH-E6(R2) GCP Training for Investigators and Study Teams accredited by Swiss Ethics, Swiss Tropical and Public Health Institute, Basel, Switzerland (2021)
  • Registration with Health Professions Council for Biomedical Scientist in United Kingdom (2013) - Registration number: BS64574
  • National Professional Certification as a Biologist, University of Naples "Federico II", Italy (2007).

Additional Information

  • CUSTOM SECTION https://www.linkedin.com/in/marianeve-quartuccio

Lenguage

Italian
First Language
English
Advanced (C1)
C1

Personal Details

  • Date of birth: 07/25/82
  • Nationality: Italian
  • Driving Licence: B
  • Work Permit: Swiss Permit C EU/EFTA

References

References available upon request.

Timeline

CLINICAL OPERATIONS SPECIALIST

Sintetica SA, Mendrisio San Martino
01.2024 - 12.2024

CLINICAL TRIAL ASSOCIATE

CSL Vifor International
06.2022 - 10.2023

Clinical Coordinator - Samples Management

F. Hoffman La Roche Ltd
11.2017 - 05.2022

Quality Assurance Specialist

Quotient Ltd
01.2017 - 10.2017

MEDICAL LABORATORY SCIENTIST

12.2013 - 12.2016

Biomedical Scientist

Public Health England
10.2012 - 11.2013

RESEARCH ASSISTANT

Imperial London Collage
03.2011 - 10.2012

BIOLOGIST

Salam Centre for Cardiac Surgery Hospital, NGO Emergency
04.2008 - 11.2008

BIOLOGIST

Health and Care National Service
01.2007 - 05.2011

MASTER DEGREE - MEDICAL BIOTECHNOLOGY

University of Study of Naples "Federico II

BACHELOR - HEALTH BIOTECHNOLOGY

University of Study of Naples "Federico II
MARIANEVE QUARTUCCIO