• Clinical Research Associate

    Experience as a CRA minimum 1-2 years

    Performance of monitoring activities of all assigned clinical studies in accordance with regulations, SOPs and Good Clinical Practices guidelines...

    LOCATION 
    • Paris, France: Headquarter
     USA : Home-based 

    RESPONSIBILITIES 
    Performance of monitoring activities of all assigned clinical studies in accordance with regulations, SOPs and Good Clinical Practices guidelines: 

     Site selection, initiation, monitoring and close out visits
     Management and coordination of all documentation study related, including Case
      Report Forms and Data Correction Forms, in collaboration with the Clinical Project
      Manager
     Management of Investigational Medicinal Products: shipment, accountability,
      reconciliation, return, filing of related documentation 
     Support to the Clinical Project Manager for regulatory submissions, essential
      documents collection
     Filing General Study Master File and Site Master Files 

    LINE MANAGEMENT 
     Clinical Operations Manager BACKGROUND 
     Scientific background (e.g. graduate degree in Biomedical sciences) 
     Experience as a CRA minimum 1-2 years 
     Fluency in English 

    Please submit a CV and cover letter at: careers@ab-science.com 

    Although each application is taken into consideration, only selected candidates will be contacted. We are an equal opportunity employer.
  • Clinical Project Manager

    5 year-experience in clinical development

    To manage the setting up and the monitoring of clinical trials within the scope of the clinical development of AB science products in compliance with SOPs,...

    LOCATION
    • Paris, France: Headquarter
     Short-hills, New Jersey, USA : US Office 

    RESPONSIBILITIES 
    To manage the setting up and the monitoring of clinical trials within the scope of the clinical development of AB science products in compliance with SOPs, ICH guidelines and local/international regulations: 

    • Provide clinical expertise, strategic planning, and support for all clinical activities.
      Develop specific expertise/medical knowledge and a comprehensive
      understanding in the therapeutic fields he/she is involved.
     Write synopsis and protocol of clinical studies he/she is assigned to.
     Ensure that study protocols, informed consents, and other study documents are
      complete and consistent with FDA, EMEA or National requirements to ensure
      successful review by Competent Authorities (CA) and Institutional Review Boards
      (IRB)/Ethics Commitees(EC).
     Prepare and submit clinical trial applications to CA and IRB/EC, provide answers
      to CA and IRB/EC.
    • Perform clinical sites selection. Develop and maintain relationships with
      investigators.
     Obtain contract signatures with institutions and investigators.
     Participate to project team meetings to provide input on trial designs, and
      oversee the execution of trials.
     Supervise CRA activity to ensure initiation and monitoring visits are done
      in a proper manner.
     Ensure patients recruitment is on track and prepare contingency plan in
      case of slow recruitment.
     If appropriate, coordinate the different Clinical Research Organizations (CROs)
      in charge of the studies. Develop and follow budget for the concerned countries,
      processes outsourced.
     Write and/or review clinical study reports summarizing the results of a clinical trial
      consistent with clinical and regulatory requirements in cooperation with Medical
      Writing Department.
     Support efforts to develop scientific abstracts, presentations, and manuscripts for
      publication of clinical trial data in cooperation with Medical Writing Department.
     If appropriate, submit/exchange with FDA/EMEA to gain approval or thorough
      review by FDA/EMEA of clinical study protocols, data analysis, and clinical
      summaries.
     Perform other related duties as assigned. 

    LINE MANAGEMENT
     CEO

    BACKGROUND
     Medical Doctor, Pharm. D. or Ph.D. Scientist
     5 year-experience in clinical development
     Fluency in English
     Good knowledge of the regulatory environment of clinical trials 

    Please submit a CV and cover letter at: careers@ab-science.com 

    Although each application is taken into consideration, only selected candidates will be contacted. We are an equal opportunity employer.