医学主任/研究医生 - CD炎症 - 远程 - 客户专属
Medical Director/Study Physician - CD Inflammation - Remote - Sponsor Dedicated
当我们的价值观一致时，我们能够实现无限可能。
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源于一种特别的东西——对所做工作的深刻信念。
无论我们在Parexel做什么，每个人都在为最终惠及患者的疗法开发做出贡献。我们认真对待工作，带着同理心去做，并致力于带来改变。
Parexel目前正在寻找一位经验丰富的研究医生加入英国或德国的团队。你将被分配到EMEA地区的一个重要客户处。
作为研究医生，你将在临床试验的准备、实施和报告阶段负责医学责任。在临床试验期间，你需要从试验设计大纲到临床试验报告提供医学专业知识和医学监督。
这是试验团队中的核心角色。
以下是该职位的一些具体要求
- 专注于一个客户。
- 确保及时制定高质量的临床试验方案，尽量减少方案修改。
- 通过定义医学相关数据和相关风险，将其纳入质量与风险管理计划，为基于风险的质量管理做出贡献。
- 联合撰写临床质量监查计划。
- 对医学数据进行持续审查。
以下是该职位的一些具体要求
- 医师（MD）（最好是拥有医学论文），接受过临床培训，且至少有4年活跃的临床实践经验；在肺病学、免疫学、内科、传染病、全科医学、儿科、风湿病学和急诊医学领域有专长者尤为受欢迎。
- 在制药行业或CRO公司具有医学或项目管理或全球药物警戒职能或其他相关医学职能的经验，最好是在临床开发领域。
- 理解相关法规和指南，包括ICH-GCP。
- 有医学监查员经验者优先考虑。
- 熟悉数据可视化系统和IT系统者优先考虑。
- 具有临床开发/试验经验者将是一个额外优势。
最初发布于Himalayas
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.
Parexel is currently seeking an experienced Study Physician to join us in the UK or Germany. You be assigned to one of our key sponsors in the EMEA region.
Working as a Study Physician you will be medically responsible at the trial level throughout the preparation, conduct and reporting phase of clinical trial. During the clinical trial, you will be responsible to provide medical expertise and medical oversight from the Trial Design Outline to the Clinical Trial Report.
This is a core role within the trial team.
Some specifics about this advertised role
- Dedicated to one client.
- Ensure timely preparation of high medical quality clinical trial protocols, minimising protocol amendments.
- Contribute to trial risk-based quality management, by defining medically relevant data and related risks are integrated into the quality and risk management plan.
- Co-author Clinical Quality Monitoring plans.
- Performing ongoing reviews of medical data.
Here are a few requirements specific to this advertised role.
- Physician (MD) (ideally with medical thesis), trained in a clinical setting, and minimum of 4 years of active clinical practice experience; specialization in Pulmonology, Immunology, Internal Medicine, Infectious Diseases, Family Medicine, Pediatrics, Rheumatology, and Emergency Medicine is highly desirable.
- Experience in pharma industry or CRO in medical or project management or global pharmacovigilance functions/ any other relevant medical function ideally in Clinical Development is desirable.
- Understanding of relevant regulations and guidance including ICH-GCP.
- Ideally previous experience as a medical monitor
- Ideally experienced with data visualization systems and IT systems.
- Clinical development/trials experience which would be an additional asset
Originally posted on Himalayas