站点激活合作伙伴 - FSP
Site Activation Partner - FSP
当我们的价值观一致时，我们能实现的没有极限。
在Parexel，我们都有相同的目标——改善全球健康。从临床试验到监管、咨询和市场准入，我们提供的每项临床开发解决方案都有一个特别的支撑点——对所做工作的深刻信念。
无论我们在Parexel做什么，都为最终惠及患者的疗法开发做出贡献。我们认真对待工作，以同理心去做，并致力于带来改变。
Site Activation Partner I 负责领导或支持指定研究和研究者站点从启动到结束的运营活动，确保符合研究时间表，并遵循现行法律、良好临床实践和发起方标准。其他职责包括但不限于：
- 启动并协调活动及关键文件管理，以编制高质量的研究者启动包（IIP），从而获得站点启动批准
- 提供支持以解决相关问题或疑虑，并在适用时及时上报站点问题
- 管理并协调其他支持角色，确保站点及时启动和运营活动
- 与所在国家的监管团队合作，并提供相关/适用的站点文件，以及在需要平行提交（监管机构和伦理）的国家
- 准确更新和维护临床试验系统，以跟踪项目时间表内的站点合规性和表现
- 识别并解决研究者站点的问题
此职位所需经验：
- 学历证书或同等教育、培训和经验组合；生命科学专业本科/学士学位优先
- 在临床试验环境和临床站点启动方面至少2年相关经验
- 在制药行业或CRO工作的经验是加分项
- 熟悉临床试验方法、ICH/GCP、FDA以及全球和当地国家法规
- 必须精通本地语言和英语。多语言能力是加分项
最初发布于喜马拉雅山
查看英文原文
When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
The Site Activation Partner I is responsible for leading or supporting operational activities from start-up to close-out, for assigned studies and investigator sites to ensure compliance with study timelines and in accordance with prevailing laws, Good Clinical Practices, and sponsor standards. Other duties to include but not limited to:
- Initiate and coordinate activities and essential documents management towards the compilation of a high-quality Investigator Initiation Package (IIP) leading to approval for sites initiation
- Provide support to resolve issues or concerns and timely escalation of Site issues where applicable
- Manage and coordinate with other supporting roles to ensure timely site activation and operational activities
- Collaborate with in country regulatory group, and provide related/applicable site documents, as well as in countries where parallel submissions (Regulatory authority and ethics) are required
- Accurately update and maintain clinical trial systems that track site compliance and performance within project timelines
- Identify and resolve investigator site issues
Experience required for this role:
- School diploma/certificate with equivalent combination of education, training and experience; BS/BA or bachelor’s degree in life sciences preferred
- Minimum 2years relevant experience in Clinical Trials environment and clinical site activation.
- Experience working in the pharmaceutical industry/or CRO is an asset
- Knowledge of clinical trial methodologies, ICH/GCP, FDA and Global and local country regulations
- Must be fluent in Local language and in English. Multi-language capability is an asset
Originally posted on Himalayas