长沙招聘

工作职责:

1. As the CRA to conduct the site QC, and ensure the site’s quality and GCP compliance.

2. Support PM to manage Menarini sponsored PK, BE, and phaseIII studies, assist to oversight study vendors to ensure successful conduction of assigned study activities to agreed budget, timeline, quality & compliance and TMF filing.

3. Oversee Investigational Products and clinical supplies management.

4. Manage all study essential documents to be collected and archived timely.

5. Coordinate and track external vendor milestone payment.

6. Manage the company supported ISS(investigator-sponsored study), closely track study progress, budget and supplies. Ensure study management in compliance with GCP, SOP and regulation. Negotiate with internal and external stakeholders to ensure the whole process going smoothly and raise the issues in time.

7. Collaborate with cross-functional department such as Regulatory Affair, Sales & Marketing, IT, Finance and Legal to support project milestone achievement.

8. May support other assigned functional activities if needed.

任职资格:

1. Bachelor degree in a health care discipline, clinical medicine or pharmacy

2. At least 3-4 years of clinical operation experience, have basic knowledge of all phases for the drug development process, phase I studies and medical device experiences are preferred.

3. Familiar with clinical trial SOPs, GCP, CFDA regulations

4. Good self-learning, problem-solving, communication, and execution

5. Fluent in English, and familiar with the excel, office, and PPT

泰格医药是行业领先的一体化生物医药研发服务平台，为全球制药和医疗器械行业提供跨越全周期的临床研究创新解决方案。通过全面的服务体系和***的质量标准，我们助力生物医药产业提升研发效率、降低研发风险，确保研究项目高质量交付，加速医药产品市场化进程，履行对行业和患者的承诺。同时，我们也通过覆盖各领域的80多家子公司，打造赋能全产业链的创新生态，推动医疗产业创新和发展。作为全球化的研发平台，泰格医药在全球布局170多个办事处和研发基地，拥有超过8600人的专业团队，覆盖5大洲的51个国家，致力于解决最具挑战的全球健康问题，满足患者的未尽医疗需求，创造社会价值，造福人类健康。