Clinical Operations Manager Regulatory

4 weeks ago


Toronto ON, Canada Parexel Full time

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.

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