临床医生/临床经理
Clinician/Clinician Manager
当我们的价值观一致时，我们能够实现的没有界限。
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建立在一种特殊的理念之上——对所从事工作的深刻信念。
无论我们在Parexel做什么，每个人都在推动最终能惠及患者的疗法的发展。我们认真对待工作，以同理心去完成，并致力于带来改变。
关键职责：
通用职责
- 为临床试验策略和方案开发过程提供临床和科学专业知识，包括了解竞争产品知识。
- 与内部贡献者（如统计学家、结果研究（OR）专家、临床药理学家、临床项目经理、区域临床站点负责人（RCSL）、市场准入同事、商业开发同事）、内部专家（如临床项目负责人、全球临床负责人、全球临床战略负责人）和外部专家（如研究者、关键意见领袖、顾问委员会成员）合作，设计/撰写临床试验大纲、方案和修订。
- 制作（并在适当情况下进行）临床/方案培训材料，用于研究和站点管理，以及在站点启动访问和研究者会议期间使用。
- 协助建立并监督数据监测委员会（DMCs）和终点裁定委员会，包括制定章程、合同、提供相关数据和记录结果。
- 通过现场访问、电话联系、电子邮件等方式直接与研究站点保持联系，以促进研究者参与，解答研究者关于方案或试验产品的疑问，并支持招募活动。对于美国、加拿大、日本和中国以外的站点，这将与RCSL合作进行。对于某些研究，临床医生可能需要承担以下描述的站点联络职责的扩展角色。
遵守Parexel标准
- 遵守所需的培训课程。
- 准确完成工时表。
- 按要求提交费用报告。
- 按要求更新简历。
- 保持对Parexel流程、ICH-GCP和其他适用要求的了解并遵守。
- 强大的沟通能力
- 展示出项目管理能力
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.
Key Accountabilities:
General Accountabilities
- Provides clinical and scientific expertise to the clinical trial strategy and protocol development process, including acquisition of knowledge of competitor products.
- Designs/writes clinical trial outlines, protocols and amendments, in collaboration with internal contributors (e.g. statisticians, Outcomes Research (OR) specialists, clinical pharmacologists, clinical project managers, Regional Clinical Site Leads (RCSLs), market access colleagues, commercial development colleagues), internal experts (e.g. clinical program lead, global clinical lead, global clinical strategy lead), and external experts (e.g. investigators, key opinion leaders, advisory board members)
- Creates (and where appropriate, delivers) clinical/protocol training materials for study and site management and for use during site initiation visits and investigator meetings.
- Helps establish and oversees Data Monitoring Committees (DMCs) and endpoint adjudication committees, including chartering, contracts, provision of relevant data and documentation of outcomes.
- Maintains direct contact with investigative sites through site visits, telephone contacts, email etc., in order to facilitate investigator engagement, address investigator questions regarding the protocol or the investigational product, and support enrolment activities. This is done in conjunction with RCSLs (when assigned) for sites outside US, Canada, Japan and China. For some studies the clinician may take on an expanded role as described below for the site liaison responsibilities.
Compliance with Parexel standards
- Comply with required training curriculum.
- Complete timesheets accurately as required.
- Submit expense reports as required.
- Update CV as required.
- Maintain a working knowledge of and comply with Parexel processes, ICH-GCPs and other applicable requirements
- Strong Communication Skills
- Demonstrated project management / leadership experience
Skills:
· Demonstrated project management / leadership experience
Knowledge and Experience:
- Preferred: Thorough understanding of local / international regulations applicable to clinical trials (pre and post approval). Practical experience in clinical trial strategies, methods and processes. Track record of design, oversight and interpretation of clinical studies. Previous leadership /management experience or training.
- Knowledge and experience in Good Clinical Practices.
- Fluent in both oral and written English.
- Fluent in host country language required.
Education:
· Fluent in host country language required.
Originally posted on Himalayas