Belgique 20.07.2021

Clinical Research and Development Specialist

Tasks

AIXIAL is an International Contract Research Organization (CRO), a member of the ALTEN Group, providing complex services in clinical trials (phase I-IV) and non-interventional studies. Our offices are located in France, Belgium, Switzerland, Germany and Czech Republic.

We are currently looking for a Clinical Research and Development Specialist to participate in Phase I-IV Clinical Development activities within a program(s) to ensure a high quality and on-time delivery of all clinical data that will allow world-wide registration in compliance with the clinical development plan, good clinical practices (GCP), and client’s standard operating procedures (SOP).

The activities include (but are not limited to):

  • Supervising the study conduct and serve as the scientific/medical accountable for the overall delivery of the trial
  • Design clinical trial protocols, and author clinical study reports
  • Review scientific and medical quality and timeliness of clinical trial synopses and protocols and all clinical trial documents, including Investigator’s Brochure and Trial Master File
  • Serving as a scientific and management reference for the project (internally/externally)
  • Liaise with Pharmacovigilance to develop Risk Management Plans and safety reports (PSUR, DSUR)
  • Actively participate and engage within the project team
  • Participate in preparing the clinical portion of the regulatory files, including labeling
  • Provides medical support to Marketing/Business Development throughout product life cycle

 

Requirements

Requirements:

  • Medical Doctor degree (or PhD with clinical trials exp.)
  • At least 1-5 years of involvement in clinical research or drug development (experience in Phases I through IV preferred), or working in a scientific or medical institution as Principal Investigator/Medical Monitor
  • Good scientific understanding of vaccines/immunology/pediatrics
  • Ability to operate effectively in multicultural matrix organization
  • Team player and very good interpersonal + leadership skills
  • Experience in Pharmaceutical companies is a strong plus

 

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