Experience

Clintec

• United Kingdom
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Clinical Project Manager

  • Apr 2018 - Present

  Office based, outsourced to MSD Romania, Clinical Project Manager with responsibilities of coordinating and overseeing the execution of clinical trials for Romania and Bulgaria from country feasibility to closure of sitesOther responsibilities: performing QC site visits.

• Senior CRA

  • Aug 2016 - Mar 2018

  Office based, 100% outsourced to MSD Romania, monitoring clinical studies in Oncology, Diabetes Mellitus and Infectious Diseases.



AbbVie

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior CRA

  • Aug 2013 - Aug 2016

  Main responsibilities: Conduct all clinical site activities according with the monitoring plan and in accordance with the study timelines; Country and Site Feasibilities; Submission of CTA and Amendments to EC and CA; Budgets and Contracts Editing, Negotiating and Signing; Visits at Sites – Evaluation, Initiation, Monitoring, Training, Close-out; Collecting and Maintaining Essential Documents; Translation of documents (Informed Consent, Labels, Synopsis of Protocol, etc.); Participate in field training and mentoring new CRAs; Facilitate quality assurance audit processes; Respond to CAPA reports; Prepare/Update Working Instructions and SOPs for clinical research department;Therapeutically Areas: HCV, Oncology, GastroenterologyFDA site inspection – 11-15 August 2014 with positive outcome and no form 483 released. Show less

• Senior CRA

  • Jan 2011 - Jul 2013



SC Verum.Edu SRL

• Bucharest, Romania

• Senior CRA

  • Jul 2008 - Dec 2010

  Working as contracted CRA for Pfizer and Roche. Therapeutically Areas: Oncology, Rheumatology, Neurology Working as contracted CRA for Pfizer and Roche. Therapeutically Areas: Oncology, Rheumatology, Neurology



Actavis (now Allergan)

• Pharmaceutical Manufacturing
• 700 & Above Employee

• Drug Safety Specialist

  • Jun 2007 - Jul 2008

  Main responsibilities: Processing Individual Case Safety Reports - Extract medical information; write case narratives; MedDRA coding; Perform follow up activities; Expedited reporting to Authorities and Partners; Prepare Periodic Safety Updated Reports (PSUR) and Submit Periodic Safety Updated Reports of marketed products to authorities in accordance with legislation; Main responsibilities: Processing Individual Case Safety Reports - Extract medical information; write case narratives; MedDRA coding; Perform follow up activities; Expedited reporting to Authorities and Partners; Prepare Periodic Safety Updated Reports (PSUR) and Submit Periodic Safety Updated Reports of marketed products to authorities in accordance with legislation;



Monitoring-Force

• Bucharest, Romania

• CRA

  • Apr 2006 - Jun 2007

  Working as contracted CRA for Sanofi-Aventis. Therapeutically Areas: Diabetes Mellitus, Infectious Diseases. Working as contracted CRA for Sanofi-Aventis. Therapeutically Areas: Diabetes Mellitus, Infectious Diseases.



National Medicines Agency (Romania)

• Bucharest, Romania

• Bioequivalence Studies Assessor

  • May 2004 - Apr 2006

  Responsibilities: Evaluation of clinical and pre-clinical documentation from the product file submitted to NAMMD; Evaluation of bioequivalence studies. Elaborate the final report for each product evaluated; Translations of the guidelines from EMEA. Responsibilities: Evaluation of clinical and pre-clinical documentation from the product file submitted to NAMMD; Evaluation of bioequivalence studies. Elaborate the final report for each product evaluated; Translations of the guidelines from EMEA.