Clinical Operations Manager Regulatory

3 tygodni temu


Bydgoszcz, Polska Pharmiweb Pełny etat
W 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.

Doświadczenie wymagane do pełnienia tej roli:

Obowiązkowe:

- 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.
- Doświadczenie w samodzielnym przygotowywaniu zgłoszeń (CTC pomaga w gromadzeniu dokumentów) zarówno do KE, jak i RA.
- Doświadczenie w przygotowywaniu ICF przy użyciu szablonów.
- Wykwalifikowana znajomość lokalnego środowiska regulacyjnego, procesów składania i zatwierdzania wniosków oraz zrozumienie, w jaki sposób wpływają one na rozpoczęcie badania.
- Doświadczenie w zarządzaniu dostawami IMP na poziomie lokalnym (dostawcy dostarczający leki podstawowe, standard opieki itp.)
- Doświadczenie w walidacji przetłumaczonych dokumentów.
Pożądane:
- 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 marta.kuniewicz@parexel.com

#LI-REMOTE

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