Regulatory Affairs Clinical Trials GCP-ICH Project Management

Kelly Caroline Guimarães Mattana

*****@**********.*** • 202-***-****

*** ************* ******, **, ********* 502

Washington, DC 20001

SUMMARY

Detail-oriented Pharmacist professional with +7 years of experience in Regulatory Affairs in international clinical trials at pharmaceutical company and CRO (Contract Research organization). My greatest strength is time management. It enables me to initiate and close projects ahead of schedule. Currently, I am pursuing a Master’s degree in Project Management.

EXPERIENCE

Georgetown University – Lombardi Cancer Center Washington, DC

Clinical Trial Assistant August 2016 – January 2017

Reviewed data management system (e-CRF) completion for quality control.

Supported the study research coordinator to submit new trials and protocol amendments to FDA and IRBs.

Coordinated to the exportation of investigational products.

Novo Nordisk S/A (Danish Pharmaceutical Company) São Paulo, Brazil

Senior Regulatory Affairs Specialist in Clinical Trials November, 2012 – April, 2016

Submitted 20 international clinical trials in diabetes, obesity and hemophilia to the Brazilian Health Surveillance Agency (ANVISA) and IRBs.

Reviewed informed consent form to comply with ICH-GCP, SOPs, and ethical and regulatory regulations.

Prepared annual reports for submission to the Brazilian Health Surveillance Agency.

Reduced the timelines of regulatory approval in 20% by applying updating templates and benchmarking the best practices.

Controlled clinical trials timeline for approval and initiation in Brazil.

Negotiated timelines with the Principal Investigators and regulatory staff for submission to IRBs.

Reviewed the SOP of pharmacovigilance by creating a workflow for Serious Adverse Events (SAE) distribution and submission.

Answered queries raised by the Brazilian Health Surveillance Agency and IRBs.

Trained study coordinators of 15 clinical sites on the submission process to the IRB.

Trained interns and new employees in their roles in the clinical trials department.

Trained the clinical trials team on e-TMF (Trial Master File) system.

Eurotrials (Portuguese Contract Research Organization) São Paulo, Brazil

Clinical Trials Specialist July, 2010 – November, 2012

Submitted 30 clinical trials in inflammation, cardiovascular, oncology and medical devices to IRBs and the Brazilian Health Surveillance Agency.

Coordinated 22 contracts signatures to initiate sites in Brazil.

Adapted 8 informed consent form to comply with ethical and regulatory regulations.

Performed drug accountability during monitoring visits.

Collected documents during 3 Site Initiation Visits (SIV) and 2 Quality Visits (QV).

Collected and reviewed essential documents for the study initiation inn Brazil (FDA1572, CV, financial disclosure, site staff certifications).

Givaudan do Brasil Ltda. (Swiss manufacturer of flavors and fragrances) São Paulo, Brazil

Administrative Assistant July, 2009 – June, 2010

Updated Latin American systems for fragrances production in Brazil and Argentina.

Prepared regulatory affairs documents for fragrances approval in Brazil.

EDUCATION

Georgetown University Washington, DC

Master of Science in Project Management Expected July, 2017

Relevant Coursework: Ethics; Risk Management; Project Planning; Project Execution; Communication for Managers; Project Analytics.

GPA: 3.89

Getúlio Vargas Foundation (FGV) São Paulo, Brazil

Certificate in Business Management December, 2015

Getúlio Vargas Foundation (FGV) São Paulo, Brazil

Certificate in Project Management December, 2014

University of São Paulo (USP) São Paulo, Brazil

Bachelor of Pharmacy and Biochemistry December, 2012

Relevant Coursework: Physiology, Human Anatomy, Immunology, Pharmacodynamic, and Pharmacokinetics.

VOLUNTEER

PMI – Project Management Institute Washington, DC

Volunteer March, 2017

Assisted in the organization of the Monthly Chapter Event.

Novo Nordisk S/A São Paulo, Brazil

Member of the Board of the Take Action Committee January, 2014 – December, 2014

Selected projects to receive investments per the company’s goals and culture.

Coordinated social projects: donation of clothing, toys and food to daycare centers.

Participated as doctor clown to attend hospitalized children and adults.

COURSES

2016 PDA/FDA Joint Regulatory Conference and PDA Data Integrity Workshop Washington, DC

September, 2016

FDA- Regulatory Education for Industry (REDI) – Fall Conference Silver Spring, MD

September, 2016

SKILLS

Languages: Portuguese (native); English (fluent); and Spanish (intermediate level)

Excellent interpersonal skills

Efficient time management skills

Detail oriented and self-motivated

Knowledge of MS Project

PUBLICATIONS

Kelly Silva et al., “Structured lipids obtained by chemical interesterification of olive oil and palm stearin” in Food Science and Technology, vol. 43, no. 5, pp. 752-758, 2010.

Co-author - Kelly Silva et al., “Effects of chemical interesterification on physicochemical properties of blends of palm stearin and palm olein” in Food Research International - FOOD RES INT 2009 vol. 42, no. 9, pp. 1287-1294.

Co-author - Kelly Silva et al., “Interesterification of Lard and Soybean Oil Blends Catalyzed by Immobilized Lipase in a Continuous Packed Bed Reactor” in Journal of the American Oil Chemists Society - JAMER OIL CHEM SOC, pp. 1-9.

AWARDS:

University of São Paulo (USP) São Paulo, Brazil

Best oral presentation at the Pharmaceutical Science and Technology Week of USP September, 2009

Scientific paper: “Structured lipids obtained by chemical interesterification of olive oil and palm stearin”

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