Rudiger HASSELBERG

En résumé

Entreprises

• Hays Pharma - Stallergenes - Clinical Project Manager

  2017 - maintenant Clinical Project Manager / Medical Review / Data Review / Data Validation

• Excelya / sanofi - Clinical Project Manager

  2016 - 2017 Clinical Trial Operation Manager (June 2016 - July 2017) Late Phase - 8 countries - 800 patients Late Phase - 8 countries - 800 patients
  Close study follow-up with affiliates and vendors: - Overall management of activities to comply with short timelines - Patient enrolment - Crfs Completion - Monitoring, Queries & issues resolution - Collect and analysis coordination of qualitative deviations

• Institut Gustave Roussy - Project Manager / Clinical Research associatA

  Villejuif 2010 - 2015 Clinical Project Manager (January 2012 - Present)
  Phase II - 8 countries - 150 patients: Pediatric oncology - Diffuse Intrinsic Pontine Glioma (DIPG)
  Phase I-II - 8 countries - 160 patients: Pediatric oncology - Low Grade Glioma
  
  Feasibility
  - Feasibility Questionnaires creation
  - Sites selection
  - Protocol review
  - eCRF review
  - Choice of service providers
  - Drug and Samples logistic
  
  Study Initiation
  - Sites Budget and contracts approvals
  - Co-sponsorship approvals
  - Development of study plans (Monitoring plan, visit report guidelines, filing/risk management plan)
  - Training of new team members
  - Active participation to co-sponsors' meeting for sites activation progress
  - Site initiation
  
  Conduct of the study
  - Manage and lead EU team for daily request
  - Ongoing review of study protocol deviations
  - Checking CRAs compliance to monitoring plan
  - Training team members
  - Checking compliance against contracted budget
  - Monitoring visit report review
  - Monitoring plan and other study guidelines creation
  - International follow-up with local sponsors
  - Steering Committee animation
  
  
  Sponsor Clinical Research associate including coordination (October 2010 - present)
  Phase II - 7 countries - 120 patients: Pediatric oncology - Neuroblastoma
  Phase I - 1 country - 45 patients: oncology - Solid Tumor
  Phase II - 1 country - 110 patients: oncology - Gynecology
  Phase II - 1 country - 60 patients - Radiotherapy
  
  - General on site monitoring responsibilities, site initiation visits
  - Contracts management
  - Investigators payments
  - eCRF, DCF management and tracking
  - Maintenance of study files
  - Protocol and amendment review
  - ICF Review
  

• Ascopharm - Clinical Research Associate

  Апатиты 2010 - 2010 Clinical Research Associate
  Phase III - Gynecology
  Phase III - Kidney transplantation
  
  - General on site monitoring responsibilities, site initiation visits
  - Contracts management
  - Investigators payments
  - eCRF, DCF management and tracking
  - Maintenance of study files

• Quintiles - Clinical Research Associate

  Durham 2009 - 2010 Clinical Research Associate
  - General on site monitoring responsibilities, site initiation visits
  - eCRF, DCF management and tracking
  - Synopsis and ICF translation

• Helpline - Coordinator / Helpdesk / International support

  Nanterre 2008 - 2008 Neurone IT - Helpline - Nanterre
  
  International Support / Helpdesk France
  Global communication of each issues regarding the network, global support.
  Account administration / Active directory.
  Hardware and Software support. Coordinateur
  Backup Manager (production & international).

• Labo-Moderne - Commercial

  2007 - 2007 Labo-moderne - Paris 15ème,
  
  Technico commercial,
  Communication with customers
  Customers potential analysis
  Laboratory supplies selling

• Sanofi-Aventis - Animal Bioexperimentation

  Paris 2005 - 2006

Formations

Pas de formation renseignée

Réseau

• Arnaud HÉROULT

• Claire BOUCHER

• Dominique SCHWOB

• Emilie MARCHETTI-DUQUESNOY

• Florence BENTOLILA

• Hélène CONSTANT

• Mélanie VERRIER

• Nelly BAUDRILLARD

• Sophie BELLOIR

• Yves SCHWARZBACH