Teodora TOBAK

En résumé

Entreprises

• Cognizant Technology Solutions - Clinical Data Manager

  Paris 2014 - maintenant Perform Data Management activities for clinical trial studies ensuring procedures and processes to meet the sponsor requirements using iMedidata RAVE data capturing system.
  * Setup and manage Phase I-II clinical studies in different therapeutic areas (Oncology,
  Diabetes, Rheumatology, Rare Diseases etc.,) as per the clinical study protocol
  * Create any study related key documentation according to CDISC - SDTM, ICH - GCP and SOPs ;
  * Act as the contact for any Data Management related issues, questions, clarifications from study team and be responsible for their solutions
  * Project Management related tasks - communication and problem solving between the different teams involved in study design and conduct activities
  * Working in a multicultural environment with multiple location around the world (France, USA, Hungary, India)
  * Participate actively in study meetings (Kick-Off Meetings, Weekly Client Meetings and
  Monitoring Meetings)
  * Responsible for EDC related trainings for CRAs, CSD, PI and clinical team
  
  Setup Experience:
  * Design the electronic case report form (eCRF) as per the study protocol
  * Initiate the Data Validation Specification (DVS) including derivations and dynamic checks as per the study requirements
  * Perform User Acceptance Testing (UAT) to ensure the consistency and accuracy of the clinical study database
  * Creation of eCRF Completion Guideline (CCG) to provide guidance for the Investigators and Study Staff as per the client requirements
  * Create any SAS Related Listings and SAS Reports Specifications ;
  * Create Patient Profile specification ;
  * Create Data Transfer File Specifications as per Third Party Vendor requirements
  * Develop and maintain documentation and data management guidelines such as DMP or any other study specific document
  
  Conduct Experience:
  
  * Data review and cleaning of the study database ;
  * Discrepancy and Query Management
  * Protocol Deviation Management ;
  * Responsible for SAE/AESI Reconciliation and Third Party Data Reconciliation
  * Review of the Validation Listings and Patient Profile data
  * Creation of Metrics Reports to follow the recent status of the study database
  * Responsible for all the Data Management related tasks in case of an interim analysis or database lock
  * Working in strong connection with CRAs, Investigators and Study Staff to ensure proper data reporting

• Gedeon Richter Plc. - Trainee

  2013 - 2014 Performed research project in the field of mammalian cell (CHO) cultivation connecting to monoclonal antibody production
  * Development of improved bioreactor processes for maximizing process productivity
  * Gained experience with common mammalian cell culture techniques, media preparation,
  process control of bioreactors
  * Familiar with protein isolation and purification techniques, molecular biology methods
  (DNA isolation, DNA Gel Electrophoresis, FACS)
  * Working experience in an aseptic laboratory environment
  * Working according to cGMP guidelines and quality documents (SOP-s)
  * Scientific publication ("Impact of apoptosis on the on-line measured dielectric properties
  of CHO cells") has been accepted for publication in Bioprocess and Biosystems Engineering

• Gedeon Richter Plc. - Intern

  2012 - 2012 * Sample preparation and analyzing pharmaceuticals with HPLC
  * Participating in the production optimization of organotherapeutic products
  

• Budapest University of Technology - Laboratory assistant - Scientific research

  2011 - 2013 Scientific research in the field of new pharmaceutical technologies
  * Investigated the applicability of a new technology (electrospinning) to produce solid
  drug formula from aqueous solution with the lowest loss of activity
  * Hands-on experience with freeze drying of bacterias and electrospinning
  * Microbiological tasks with bacteria (Lactobacillus acidophilus) cultures
  * Research published in the New Biotechnology in 2013 (I. I. Wagner, Nagy Z. K., Á.
  Suhajda, T. Tobak, A. H. Harasztos, H. Pataki, G. Marosi, Solid Dosage Form of Living
  Bacteria Prepared by Electrospinning. New Biotechnology. (2013) if.: 1,706)

Formations

• Budapest University Of Technology And Economics BME, BUTE (Budapest)

  Budapest 2012 - 2014 Biochemical Engineering Master Course
  
  Health Care Specialization

• Budapest University Of Technology And Economics BME, BUTE (Budapest)

  Budapest 2008 - 2012 Biochemical Engineering Bachelor Course
  
  Health Care Specialization

Réseau

• Marie-Anne MICK

• Olivier PERROT

• Oriane MITH

• Sarah ROUSSEL - MONTELEONE