Danielle Oliveira

  • Sao Paulo Brazil
Danielle Oliveira

Summary

• Ten years experience working with local and global clinical researches in pharmaceutical companies.• Strong experience to coordinate specialized and multi-disciplinary teams.• Good experience in audits, process and quality controls of the clinical trials.• Additional experience coordinating the clinical supplies area and the financier of the projects.

Work History

Work History
Jan 2008 - Jan 2009

Clinical Study Manager

Roche Pharmaceuticals

Therapeutic Areas: Rheumatology (arthritis), Virology (hepatitis B and C)

  • Therapeutic Area Leader for Rheumatology (arthritis) and Virology (hepatitis B and C) trials exceeding the goals in 75% of the clinical trials accomplished for the year.
  • Overall responsibility for the study commitments within the country and for the local strategic planning in more than 15 international clinical trials coordinating the database cleaning process.
  • Leading and optimizing the performance of the multi-disciplinary team (4 managers and more than 15 CRAs) ensuring compliance with ICH/GCP, local legislation and local and global procedures.
  • Reorganization and improvement of the financial and administrative clinical trial’s controls, providing reliability of each project.
  • Development and maintenance of the relationship with internal and external partners (clinical sites, laboratories, study teams and other support areas - legal department, market department, financial department and local clinical research department).

Mar 2007 - Jan 2008

Local Study Delivery Team Leader

AstraZeneca Pharmaceuticals

Therapeutic Areas: Oncology (breast cancer, lung cancer), Central Nervous System (schizophrenia), Respiratory (asthma, CPOD), Metabolism (hypercholesterolemia, diabetes type II)

  • Planning, organization and delineation of the strategies to patient’s recruitment and conducting more than 17 local and global clinical trials achieving the established goals.
  • Development of a project to decrease the study start-up phase, in collaboration with a multifunctional team, obtaining 25% of reduction of the initial plan.
  • Development of a tool to distribute concomitant medication to patients in a partnership with the drugstore Droga Raia.
Jul 2005 - Mar 2007

Clinical Process Manager

AstraZeneca Pharmaceuticals

  • Reorganization and improvement of the clinical research department procedures to guarantee that the clinical studies were conducted in accordance with local legislation and local and global procedures.
  • Organization and promotion of local internal audits in all projects conducted in the country, providing reliability of the clinical data. Through this activity in 2006, Brazil was considered for the first time, one of the first countries with good quality to conduct clinical trials.
Jan 2004 - Jul 2005

Study Drug Coordinator and Financial Coordinator for Global Clinical Trials

AstraZeneca Pharmaceuticals
  • Revision and improvement of the local controls and procedures of the Depot, obtaining 15% of the time reduction in the importation process, providing traceability and reliability.
  • Evaluation and report of the clinical trials financial data to the head office, organizing and improving local financial procedures, allowing that the annual budget planned for the clinical trials didn’t vary in 5% of the real budget.
Jul 2002 - Jan 2004

Clinical Research Associate

AstraZeneca Pharmaceuticals

Therapeutic Areas: Oncology (breast cancer), Cardiovascular (hypertension, thrombosis), Respiratory (asthma)

  • Preparation and submission of the regulatory documents to IRB/IEC and local regulatory authorities (ANVISA).
  • Monitoring of local and international clinical trials.
  • Investigator’s meeting planning.
Nov 1999 - Jul 2002

Clinical Research Associate

Zerbini Foundation

Therapeutic Areas: Cardiovascular (hypertension, thrombosis)

  • Preparation of protocols and Case Report Forms (CRF).
  •  Preparation and submission of the regulatory documents to IRB/IEC and local regulatory authorities (ANVISA).
  • Monitoring of local and international clinical trials.
  • Investigator’s meeting planning.
Jan 1998 - Oct 1999

Supervisor Pharmacist

Heart Institute - InCor

Internal hospital unit pharmacist and responsible pharmacist for clinical trials.

Education

Education