Descrizione dell'offerta
Experteer Overview
In this role you drive GCP compliance within clinical development, acting as a QA reference for project teams. You’ll implement and maintain the quality system in GCP areas and support study design, execution, and reporting. You will review key clinical documents, manage breaches and deviations, and support regulatory inspections. You’ll also author SOPs and ensure alignment with current regulations, collaborating with R&D and clinical teams to sustain high-quality, compliant trials. Retribuzione / Benefits
Act as QA GCP reference for clinical project teams across organic and inorganic growth Implement and maintain the GCP quality system Review clinical study documentation (protocols, amendments, patient information sheets, informed consent, CSR) Manage Suspected Serious Breaches and GCP deviations Support preparation and follow-up of GCP inspections by Regulatory Authorities Manage GCP deviations and non-conformances Create SOPs and working instructions for R&D QA GCP activities Review SOPs for clinical studies to ensure regulatory compliance Responsabilità
At least 3 years’ experience as clinical QA in pharmaceutical companies or clinical CROs OR at least 3 years’ experience in clinical studies as CRA or Project Manager in pharma or CROs Scientific degree, Pharmacist or Life Sciences Deep English knowledge (spoken and written) Knowledge of GCP regulations Proficiency with common computer tools (e.g., Office) Requisiti fondamentali
comprehensive healthcare programs work-life balance initiatives relocation support flexible working arrangementsremote work options tax assistance services for foreign colleagues
#J-18808-Ljbffr
In this role you drive GCP compliance within clinical development, acting as a QA reference for project teams. You’ll implement and maintain the quality system in GCP areas and support study design, execution, and reporting. You will review key clinical documents, manage breaches and deviations, and support regulatory inspections. You’ll also author SOPs and ensure alignment with current regulations, collaborating with R&D and clinical teams to sustain high-quality, compliant trials. Retribuzione / Benefits
Act as QA GCP reference for clinical project teams across organic and inorganic growth Implement and maintain the GCP quality system Review clinical study documentation (protocols, amendments, patient information sheets, informed consent, CSR) Manage Suspected Serious Breaches and GCP deviations Support preparation and follow-up of GCP inspections by Regulatory Authorities Manage GCP deviations and non-conformances Create SOPs and working instructions for R&D QA GCP activities Review SOPs for clinical studies to ensure regulatory compliance Responsabilità
At least 3 years’ experience as clinical QA in pharmaceutical companies or clinical CROs OR at least 3 years’ experience in clinical studies as CRA or Project Manager in pharma or CROs Scientific degree, Pharmacist or Life Sciences Deep English knowledge (spoken and written) Knowledge of GCP regulations Proficiency with common computer tools (e.g., Office) Requisiti fondamentali
comprehensive healthcare programs work-life balance initiatives relocation support flexible working arrangementsremote work options tax assistance services for foreign colleagues
#J-18808-Ljbffr
Candidatura e Ritorno (in fondo)
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