Clinical Compliance Specialist R&d
4 giorni fa
Our client, Chiesi Farmaceutici - one of the top 50 pharmaceutical companies in the world, with more than 80 years of experience within the pharmaceutical and biotechnology industry - in order to expand their staff, entrusted to IQVIA the recruitment of a Clinical Compliance Specialist R&D who can join an exciting working environment in a dynamic and international atmosphere.
JOB DESCRIPTION:
To contribute to the implementation of new and existing regulatory requirements about Clinical Trials in the Quality management system. To support the training activities on the SOPs and to raise awareness on best practices in Clinical trials.
RESPONSIBILITIES:
- Assists manager in providing the Monitoring of Regulatory Requirements in relation to clinical trials.
- Collaborates on development of standard operating procedures, trainings, and documentation. Delivers SOPs trainings.
- Support process improvement efforts, assessment and alignment to the international standards, regulations and guidelines, and review of procedural updates as needed.
- Participate in departmental initiatives across Clinical Dev. Dept sought at improving process and efficiency, in particular for the improvement of compliance processes.
- Support audit-related activities and respond to internal audits including CAPA plans, training, procedure modification and implementation.
**REQUIREMENTS**:
- At least 3 year in clinical research regulatory and/or compliance.
- Good knowledge of ICH GCP, international (EU, US) regulatory requirements and company SOPs about Clinical Trial.
- Good understanding of regulatory requirements about Clinical Trials and Clinical Trial Transparency.
- English intermediate
TYPE OF CONTRACT:
Temporary contract
Chemical contract
LI-CES
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world. Learn more at
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