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Profile Details

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USD 70 /hr

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Hire Elsa M.

Portugal

USD 70 /hr

Clinical Project Manager & QPPV @ ICNAS-Produção

Profile Summary

Excellent team spirit, own initiative, love teamwork, responsibility and capacity
to manage conflicts, ability to adapt to different contexts, spirit of Leadership, excellent skills of
communication, negotiation and networking. Total availability and willingness to
travel. Motivation to work by objectives, Innovation, project management, creative thinking and a huge love for science

Extensive experience in:
Design and Project management of Interventional Clinical Studies – Areas: Neurology; Cardiology and Oncology (Imaging Phase 3 and Phase 4 Clinical Trials with IMP; Medical Devices; Investigator’s Interventional and non-Interventional Studies without IMP)
- Clinical Trials Regulatory affairs (National and European legislation) submission to Authorities and preparation of all of the requested documentation (CTA, ICFs, Protocol, IMP information, labels, etc)
- Preparation of audits related with Annex 3 (Radiopharmaceuticals) and Annex 13 (Manufacture of Investigational Medicinal Products) from Eudralex vol 4 – GMPs
- Preparation of labels, SOPs and Sponsor Files according to GMPs
- Preparation of Trial Master Files and Investigator Site Files according to ICH-GCP
- Preparation of budget analysis, risk assessment, clinical SOPs, project and monitoring plans for Clinical Trials;
- Identification of Clinical Trials Suppliers at “PCT - Partnership in Clinical Trials”
- eCRF Design and Validation with Data Managers Team according with 21 CRF part 11 and GCDMP
- Risk and pharmacovigilance in clinical trials
- EudraLex Vol. 10
- Trainer of new interns

Regulatory Affairs and Quality:
- Involved in the process of obtaining GMP and Manufacturing Authorizations for IMPs
- Submission of Amendments to current marketing authorizations (knowledge in EudraLex Vol.2)
- Answering to Inspections from National Authorities in GMPs for Human Use Medicines and Experimental Medicines (EudraLex Vol. 4)

CRA in Medical Device Studies

Subject Matter Expertise

Services

Writing
Consulting
Product Development

Work Experience

Clinical Project Manager & QPPV

ICNAS Produção Unipessoal Lda

March 2017 - Present

Universidade de Coimbra Instituto de Ciências Nucleares Aplicadas à Saúde

2017 - Present

Expert in nuclear medicine and diagnostic imaging

International Atomic Energy Agency

April 2018 - April 2018

Junior Project Manager

Portuguese Institute of Oncology of Coimbra

December 2015 - March 2017

Junior Project Manager

Instituto Português de Oncologia de Coimbra Francisco Gentil EPE

2015 - 2017

Associated Investigator

IPO Porto

2012 - 2015

Associated Researcher - Virology and Molecular oncology group

Portuguese Institute of Oncology of Porto

October 2012 - December 2014

Education

The NEW EudraVigilance System and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format

European Medicines Agency (EMA) promoted by DIA Global EMEA

December 2018 - December 2018

Pharmaceutical Medicine Academy

January 2018 - December 2018

Regulatory Affairs

Eurotrials Centre for Clinical Research Training - CTI

January 2018 - December 2018

Clinical Research Monitoring Course

Eurotrials Centre for Clinical Research Training - CTI

January 2016 - December 2016

Big Data Academy course

Altran Technologies SA

2016 - 2016

Clinical Research Monitoring Course (Clinical Trials)

Eurotrials Scientific Consultants

2016 - 2016

MSC Clinical Biochemistry

University of Aveiro

January 2012 - December 2014

CCP – Certificate of pedagogic Skills

Conclusão Estudos e Formação Lda

2014 - 2014

Bsc Biochemistry

University of Aveiro

January 2007 - December 2012

Master in Applied Biology (1st year) (Biology)

University of Aveiro

2012 - 2012

Biochemistry (Chemistry)

University of Aveiro

2007 - 2012

Certifications

Certification details not provided.

Publications

JOURNAL ARTICLE

Neves, M., Marinho-Dias, J., Ribeiro, J., Neves, M., Marinho-Dias, J., Ribeiro, J., Esteves, M., Maltez, E., Baldaque, I., Breda, E., et al.(2015). Characterization of Epstein-Barr virus strains and LMP1-deletion variants in Portugal . Journal of Medical Virology. 87. (8). p. 1382-1388.