临床试验经理 - FSP
Clinical Trial Manager - FSP
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信念——对所做工作的深刻认同。
无论我们在Parexel做什么，都在为最终惠及患者的疗法开发做出贡献。我们把工作当作个人的事情，带着同理心去做，并致力于带来改变。
职位概述
临床试验经理（CTM）将作为客户开发运营团队的一员。临床试验经理将作为临床试验工作组的一部分，负责管理个别临床试验和/或项目。
主要职责：
监督相关活动
· 管理外部供应商和合同研究组织
· 准备研究文件，如监查手册、研究操作手册、源数据验证计划和实验室手册
· 协调并负责研究材料的设计，如CRF、患者日记、研究参与卡和原始记录
· 协助方案制定和研究报告完成
· 管理临床研究现场的监查活动（可能包括常规现场监查），以确保符合良好临床实践（GCP）、标准操作规程（SOP）和研究方案
· 为CRAs提供指导、方向和管理
· 跟踪受试者入组；进行资格评估、启动、监查、结题活动和审查站点报告；协助协调数据管理工作
· 协调研究物资
· 与临床试验服务供应商谈判合同
· 审核知情同意书、CRF和研究相关材料
· 计划并参与研究者会议
· 协助和支持数据查询流程
· 确保研究站点符合客户的SOP以及FDA和ICH指南的法规合规性
· 确保试验主文件保持最新并妥善维护
协作关系
· 与外部供应商和合同研究组织合作，以确保临床试验的高效执行。
遵守Parexel标准
· 遵守必要的培训课程
· 按要求准确完成工时表
· 按要求提交费用报销单
· 按要求更新简历
· 保持对Parexel标准的了解并遵守
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.
Job Overview
The Clinical Trials Manager (CTM) will be a member of client’s Development Operations team. The Clinical Trials Manager will manage individual clinical trials and/or programs as part of the Clinical Trial Working Group.
Key Accountabilities:
Oversight of activities
· Manage external vendors and contract research organizations
· Prepare study documents such as the Monitoring Manual, Study Operations Manual, Source Data Verification Plan and Laboratory Manual
· Coordinate and be responsible for the design of study materials such as CRFs, patient diaries, study participation cards and source documents
· Assist with protocol development and study report completion
· Manage monitoring activities (may include routine on-site clinical monitoring) at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs and study protocols
· Provide guidance, direction, and management to CRAs
· Track patient enrollment; qualify, initiate, monitor, perform closeout activities, and review site reports; and assist in coordination of data management activities
· Coordinate study supplies
· Negotiate contracts with vendors of clinical trial services
· Review Informed Consent Forms, CRFs, and study related materials
· Plan and participate in investigator meetings
· Assist and support data query process
· Assure regulatory compliance of investigational sites with client’s SOPs and FDA and ICH guidelines
· Ensures trial master file is current and maintained
Collaborative relationships
· Collaborate in the management of external vendors and contract research organizations to ensure efficient execution of clinical trials.
Compliance with Parexel standards
· Complies with required training curriculum
· Completes timesheets accurately as required
· Submits expense reports as required
· Updates CV as required
· Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements
Skills:
· Oversee all aspects of clinical trials from initiation to closeout, ensuring timely completion within budget through effective project management.
· Identify and resolve issues that arise in a timely manner during trial execution to minimize delays and maintain study integrity, employing strong problem-solving abilities.
· Effectively manage multiple tasks, deadlines, and priorities in a complex clinical trial environment
· Clearly convey information and expectations to cross-functional teams, investigators, and stakeholders
Knowledge and Experience:
· Good Clinical Practices (GCPs) and regulatory compliance (FDA and ICH guidelines)
· Experience in clinical trial documentation and processes (e.g., protocols, CRFs, monitoring plans)
· Experience of data management and query resolution in clinical trials
· Overall knowledge of site management and monitoring procedures
Education:
· Degree in the life sciences field preferred
Originally posted on Himalayas