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    Clinical Operations Manager Regulatory - Toronto, ON, Canada - Parexel

    Parexel
    Parexel Toronto, ON, Canada

    1 week ago

    Default job background
    Description

    Job Description

    When our values align, there's no limit to what we can achieve. Parexel FSP ludzie robią różnicę. Mamy kluczową misję: zapobiegać chorobom i leczyć je poprzez dostarczanie nowych, ważnych leków i terapii pacjentom w potrzebie. Osiągamy ten ważny cel dzięki wiedzy, doświadczeniu, innowacyjności i zaangażowaniu naszych pracowników na całym świecie.

    Nasi pracownicy mają możliwość robienia znaczących rzeczy na całym świecie, podczas gdy my wspieramy ich lokalnie w środowiskach pełnych wyzwań, współpracy, elastyczności i wiodącego w branży potencjału wzrostu. Parexel FSP poszukuje osoby na stanowisko Clinical Operations Manager Regulatory w Polsce, hybrydowo (2 lub 3 dni z biura sponsora w Warszawie).

    Na tym stanowisku będziesz odpowiedzialny za wydajność i zgodność z przypisanymi protokołami w kraju zgodnie z ICH / GCP i przepisami krajowymi, politykami i procedurami klienta, standardami jakości oraz wymogami dotyczącymi zgłaszania zdarzeń niepożądanych wewnętrznie i zewnętrznie.

    Spodziewaj się ekscytujących wyzwań zawodowych, ale z zachowaniem zdrowej równowagi między życiem zawodowym a prywatnym. Twoje dobre samopoczucie jest dla nas tak samo ważne, jak naszych pacjentów.

    Experience Required

    1. Obowiązkowe:
    2. co najmniej roczne doświadczenie w składaniu wniosków do KE i RA (musi być zaznajomiony z wypełnianiem XML) - w tym składanie wstępnych wniosków i poprawek do protokołów.
    3. Doświadczenie w samodzielnym przygotowywaniu zgłoszeń (CTC pomaga w gromadzeniu dokumentów) zarówno do KE, jak i RA.
    4. Doświadczenie w przygotowywaniu ICF przy użyciu szablonów.
    5. Wykwalifikowana znajomość lokalnego środowiska regulacyjnego, procesów składania i zatwierdzania wniosków oraz zrozumienie, w jaki sposób wpływają one na rozpoczęcie badania.
    6. Doświadczenie w zarządzaniu dostawami IMP na poziomie lokalnym (dostawcy dostarczający leki podstawowe, standard opieki itp.)
    7. Doświadczenie w walidacji przetłumaczonych dokumentów.
    8. Pożądane:
    9. Doświadczenie z budżetem krajowym i budżetem ośrodka, w tym opracowywanie, negocjowanie i wypełnianie umów dotyczących badań klinicznych oraz nadzór i śledzenie płatności związanych z badaniami klinicznymi oraz uzgadnianie płatności po zakończeniu badania.

    Więcej informacji można uzyskać pod adresem

    #J-18808-Ljbffr
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