PRAHS

  • Associate Director of Medical Affairs (Early Phase Clinical Research)

    Job Locations - | Germany-Berlin | Slovakia-Bratislava | Russia | Hungary-Budapest | Poland-Warsaw | Czech Republic-Prague
    Posted Date 2 months ago(2/27/2018 8:07 AM)
    ID
    2016-37166
  • Overview

    The Early Development Services (EDS) division of PRA is a global leader in providing early-phase clinical research and bio-analytical services to the pharmaceutical and biotechnology industries. With a reputation built on excellence, quality and professionalism, we work with leading pharmaceutical and biotechnology companies, performing clinical research and bio-analytical trials on many of the most advanced experimental drugs and biological in development today. Employees of EDS are enthusiastic and dedicated and work in a dynamic informal organization.

     

    Patient Pharmacology Services is a group within Early Development Services focusing on early-phase clinical trials in patient populations. With a management office in Berlin, and clinical operations in several countries in Central and Eastern Europe, we now have an opening for an 

     

    Associate Director of Medical Affairs

    Responsibilities

    • Review study protocols, study specific documents with respect to feasibility and medical safety
    • Support business development activities by review of study protocols/synopses/concept sheets with respect to feasibility
    • Support the PRA Medical Writer in generating a clinical study protocol/synopsis/concept sheet, Informed Consent Form or a clinical study report
    • Perform a formal risk assessment of each clinical trial for risk mitigation purposes based on the study protocol, the Investigator’s Brochure and other documents relevant from medical safety perspective
    • Support project management with generating study specific safety management plans
    • Support Quality Assurance by ensuring that SOPs and associated documents reflect the needs in performing clinical trials in special populations
    • Provide study specific training from a medical safety perspective to the clinical staff involved in the conduct of the clinical trial
    • Support PRA employees and external medical doctors involved in the conduct of clinical trials with eligibility confirmation, safety reporting, and guidance on any medical and scientific aspects
    • Interact with sponsors’/clients’ medical representatives for clarification of eligibility and medical safety aspects
    • Support data management/ statistics with reviewing coding of medical terms (MedDRA) and concomitant medications (WHO)

    Qualifications

    • Medical/MD degree, a specialization degree is a big advantage (e.g. Internal Medicine, Oncology, Nephrology, Rheumatology or any other medical discipline)
    • At least 5 years of clinical practice in e.g. a hospital
    • Read, write and speak fluent English. Russian language skills are a big advantage
    • Since you support our teams/clinics in e.g. Berlin (Germany), Prague (Czech Republic), Budapest (Hungary), Warsaw (Poland) and Bratislava (Slovakia), you are located close to either of our clinics or offices.

    How to apply?

     

    We offer a competitive salary and an excellent working environment, there are no irregular hours with this job. As we continue to expand, there will be career opportunities on a truly global scale. If you are interested in a dynamic job and career please send your application and resume.  

     

    If you require further information please contact Wytske Bijma, staff recruiting consultant on +31 50 40 22 222. Recruiting is done remotely from the Netherlands.

    PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

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