Clinical Operations Manager Regulatory

2 weeks ago

Poland, India PAREXEL International Ltd Full time  60,000 -  1,20,000 per year
Job Description

W Parexel FSP to ludzie robi rnic. Mamy kluczow misj: zapobiega i leczy choroby poprzez dostarczanie nowych lekw i terapii potrzebujcym pacjentom. Ten wany cel osigamy dziki wiedzy, dowiadczeniu, innowacyjnoci i zaangaowaniu naszych pracownikw na caym wiecie.

Nasi pracownicy maj moliwo robienia wanych rzeczy na caym wiecie, podczas gdy my wspieramy ich lokalnie w rodowiskach penych wyzwa, wsppracy, elastycznoci i wiodcego w brany potencjau rozwoju.

Parexel FSP poszukuje osoby na stanowisko Clinical Operations Manager Regulatory w Polsce.

Bdziesz odpowiedzialny/a za wykonanie przydzielonych protokow w danym kraju zgodnie z ICH/GCP i przepisami krajowymi, polityk i procedurami Klienta, standardami jakoci oraz wymaganiami dotyczcymi zgaszania zdarze niepodanych wewntrznie i zewntrznie.

Oczekuj ekscytujcych wyzwa zawodowych, ale z zachowaniem zdrowej rwnowagi midzy yciem zawodowym a prywatnym. Cenimy Twoje dobre samopoczucie tak samo jak dobro naszych pacjentw.

Wymagane dowiadczenie: Obowizkowe:
  • co najmniej 1 rok dowiadczenia w Polsce w nadsyaniu zgosze EC i RA / EUCTR (obowizkowa znajomo uzupeniania XML) - w tym zgoszenie wstpne i zgoszenie zmian do protokou.
  • Dowiadczenie w samodzielnym przygotowywaniu wnioskw (CTC wspiera w zbieraniu dokumentw) zarwno do EC jak i RA.
  • Dowiadczenie w przygotowywaniu ICF z wykorzystaniem szablonw.
  • Biega znajomo lokalnego rodowiska regulacyjnego, procesw skadania i zatwierdzania wnioskw oraz zrozumienia, w jaki sposb wpywaj one na rozpoczcie bada.
  • Dowiadczenie w zarzdzaniu dostawami IMP na poziomie lokalnym (dostawcy dostarczajcy leki podstawowe, standard opieki itp.).
  • Dowiadczenie w walidacji przetumaczonych dokumentw.
Podane:
  • Dowiadczenie w zakresie budetu kraju i placwki, w tym opracowywanie, negocjowanie i wypenianie umw dotyczcych bada klinicznych oraz nadzorowanie i ledzenie patnoci zwizanych z badaniami klinicznymi i uzgadnianie patnoci przy zamykaniu badania.

Aby uzyska wicej szczegw, skontaktuj si z lub z aplikacj bezporednio na naszej stronie internetowej

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