Maria Assunta Altamura

Clinical Project Manager at Pharma D&S
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Contact Information
us****@****om
(386) 825-5501
Location
Italy, IT
Languages
  • Inglese Professional working proficiency
  • Spagnolo Elementary proficiency
  • Italiano Native or bilingual proficiency

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Credentials

  • Document of readiness for inspection
    Pharma Education Center
    Mar, 2023
    - Nov, 2024
  • Focus on module 5 of the Common Technical Document (CTD)
    Pharma Education Center
    Nov, 2022
    - Nov, 2024
  • ERT Training
    ERT
    Sep, 2021
    - Nov, 2024
  • IATA Training - Transporting dangerous goods training
    Mayo Clinic
    Sep, 2021
    - Nov, 2024
  • Abilitazione alla professione di Farmacista
    FOFI - Federazione Ordini Farmacisti Italiani
    Jun, 2021
    - Nov, 2024
  • GCP Training for investigators
    Brookwood Global
    Jan, 2021
    - Nov, 2024
  • ECDL - European Computer Driving Licence
    AICA - Associazione Italiana per l'Informatica e il Calcolo Automatico
    Jan, 2014
    - Nov, 2024

Experience

  • Pharma D&S
    • Italy
    • Business Consulting and Services
    • 100 - 200 Employee
    • Clinical Project Manager
      • Feb 2022 - Present

      - Drafting and reviewing documents necessary for submission to AIFA: study protocol, informed consent, eCRF, patient diary, clinical project management plan and development plan. - Management of the clinical trial: contact with research centres and eCRF review. Training, management and support of CRA and monitoring visits. - Production of project SAL and negotiation of study budgets. - Drafting and reviewing documents necessary for submission to AIFA: study protocol, informed consent, eCRF, patient diary, clinical project management plan and development plan. - Management of the clinical trial: contact with research centres and eCRF review. Training, management and support of CRA and monitoring visits. - Production of project SAL and negotiation of study budgets.

  • Azienda Ospedaliero-Universitaria Careggi
    • Italy
    • Hospitals and Health Care
    • 700 & Above Employee
    • Clinical Study Coordinator
      • Apr 2021 - Feb 2022

      • Coordination of clinical research to ensure research activities comply with GCP and institutional policy • Development and implementation of a data management plan for clinical studies on neurodegenerative diseases • Maintained effective and clear communication with the Sponsor, Investigators and project staff regarding assigned projects • Coordination of clinical research to ensure research activities comply with GCP and institutional policy • Development and implementation of a data management plan for clinical studies on neurodegenerative diseases • Maintained effective and clear communication with the Sponsor, Investigators and project staff regarding assigned projects

  • Università degli Studi di Firenze
    • Higher Education
    • 700 & Above Employee
    • University Tutor
      • Feb 2020 - May 2021

    • Experimental Synthesis Research
      • May 2020 - Feb 2021

      Experimental Thesis: “Design and synthesis of new scaffolds as inhibitors of TMPRRS2 enzyme". -Rational design, synthesis and optimization of molecules endowed with biological activity through classical methodologies (isosteric substitutions, steric modulation) and advanced molecular modeling (LBDD);-Use of analytical techniques: NMR, TLC, LC-MASS;-Docking studies using a molecular homology model based on templates.

  • Farmacia di Rifredi Dr. Napoli Alessia
    • Florence
    • Pharmacy Internship
      • Nov 2019 - Feb 2020

Education

  • University of Florence
    Master's degree in Pharmacy, Pharmacy
    2015 - 2021
  • Scientific High School A. Guarasci
    Diploma
    2010 - 2015

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