Associate Director, Clinical Quality Assurance

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7m1b22

Overview

Job Title: Associate Director, Clinical Quality Assurance
Reports to: Executive Director, Quality Assurance
Location: EMEA Remote

Are you a meticulous QA professional passionate about ensuring the highest standards of GCP compliance in clinical trials? Do you thrive on driving quality improvements and preparing for regulatory inspections? Are you ready to make a significant impact on oncology treatments?
If so, join our team and be our next Associate Director, Clinical Quality Assurance, apply now

Responsibilities

About the Role:

We are seeking a highly motivated and experienced Associate Director, Clinical Quality Assurance to join our team, reporting to the Executive Director, Quality Assurance. This critical role will serve as the lead for compliance with GCP requirements for specific clinical programs and trials , providing essential GCP QA support on an as-needed basis to different trials. Your responsibilities will span from QA review of key clinical trial documentation (e.g., Clinical Protocol, Investigator’s Brochure, Informed Consent Form,



Trial Master File) , as well as relevant submission documentation. You will facilitate the assessment and investigation of quality issues by driving root cause analysis and remediation, providing expertise and recommendations, and ensuring timely closure of quality issues. Furthermore, you will facilitate the review of potential Serious Breach and Urgent Safety Measure assessments arising from assigned clinical programs. This is an exciting opportunity to contribute to building and shaping Menarini Stemline’s Oncology business.

Responsibilities:
- Responsible for QA review of key clinical trial documentation (e.g., Clinical Protocol, Investigator’s Brochure, Informed Consent Form, Trial Master File).
- Drive the assessment and investigation of quality issues, including root cause analysis, remediation, and timely closure.
- Facilitate the review of potential Serious Breach and Urgent Safety Measure assessme

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7m1b22