Beyond HR

Senior Data Analyst

Descrição

Data da Publicação:
1/4/2024

JCR Pharmaceuticals Co., Ltd. is a global Japanese multinational specializing in pharmaceuticals that is redefining expectations and expanding possibilities for people with rare and genetic diseases worldwide. They are currently looking for a Clinical Operations Manager, who will be accountable for managing and/or supporting the clinical operation activities for clinical studies. Responsibilities include leading, managing, and/or supporting the conduct of clinical trials, ensuring study inspection readiness, collaborating with cross-functional stakeholders, managing clinical sites and academic institutions, planning and reporting of clinical studies, ensuring implementation and conduct of studies in accordance with ICH-GCP guidelines, and overseeing TMF management and study budget and timelines. Requirements include a complete BsC in life sciences, minimum of 5 years' experience in clinical operations management within biotech or pharma setting, experience and knowledge of clinical project management, understanding of regulatory environment and GCP/ICH, and strong communication and interpersonal skills. This is a hybrid position, with 1x/week on-site at the office and availability for eventual travel.

Requisitos

Complete BsC in life sciences, Minimum of 5 years' experience in clinical Operations management within biotech or pharma setting, Experience & knowledge of clinical project management, Experience in oversight of external vendors (e.g. CROs, central labs, etc.), Understanding of regulatory environment, GCP/ICH, Inspection readiness, Experience working in an orphan disease field is a plus, Strong communication and interpersonal skills, with the ability to collaborate effectively across diverse functional areas

Benefícios

Hybrid position, 1x/week on site at the office, Must have availability for eventual travel

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