iCRAII
iCRAII
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建立在一种特殊的理念之上——对我们所做工作的深刻信念。
无论我们在Parexel做什么，每个人都在推动一种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。
负责根据欧洲药品管理局（EMA）通过临床试验信息系统（CTIS）规定的第II部分要求，规划并交付欧盟临床试验指令/法规（EUCTD/R）报告。与监管事务、临床试验管理和临床透明度的协调将是该职位的核心职责。
主要职责：
运营管理：
- 与监管事务职能代表合作，为涉及欧盟国家的任何即将开展的临床试验规划临床试验申请（CTA）
- 与临床试验管理职能代表合作，确定关键研究里程碑和国家分配策略
- 与临床透明度部门协调，确定CTA提交所需的相关文件的删减内容
- 确定任何一项临床试验中参与的成员国/国家列表，并将信息录入CTIS数据库
- 确定代表研究开始、研究完成、入组开始、入组完成以及可能适用的研究暂停/重新启动/取消日期的研究层面和成员国/国家层面的关键里程碑，并将相关日期录入CTIS数据库
- 确定每个临床试验将开展的成员国/国家中的机构和主要研究者，并在CTIS数据库中记录相关联系方式
- 找到适用于成员国/国家和/或现场级别的临床试验申请（CTA）提交的相关文件，并将其上传至CTIS数据库
- 在研究生命周期内维护参与的成员国/国家、机构和主要研究者的列表，以确保一致性和同步性
- 处理因录入和/
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.
Responsible for planning and delivery of European Union Clinical Trials Directive/Regulation (EUCTD/R) reporting according to the Part II requirements outlined by the European Medicines Agency (EMA) via the Clinical Trial Information System (CTIS). Coordination with Regulatory Affairs, Clinical Trial Management and Clinical Transparency will be core to the role.
Key Accountabilities:
Operations Management:
- Engage with Regulatory Affairs functional representatives to plan the Clinical Trial Application (CTA) for any one up and coming clinical trial that involves EU countries
- Engage with Clinical Trial Management functional representatives to determine key study milestones and country allocation strategies
- Coordinate with Clinical Transparency regarding any redactions required for relevant documents identified for CTA submissions
- Identify the list of Member State/countries participating in any one clinical trial and capture the information within the CTIS database
- Identify the key study level and Member State/country level milestones that represent Study Start, Study Completion, Enrollment Start, Enrollment Completion and any potential hold/restart/cancel dates that may apply to the study and capture the relevant dates within the CTIS database
- Identify the Institutions and Primary Investigators for each Member State/Country where the clinical trial will be conducted and capture relevant contact information within the CTIS database
- Locate the documents that are deemed applicable at the Member State/country and/or site level for the purposes of Clinical Trial Application (CTA) submissions and upload them into the CTIS database
- Maintain the list of participating Member States/countries, Institutions and Primary Investigator over the life cycle of the study to ensure alignment and synchronization.
- Triage any questions that surface (RFIs, Requests For Information) as a result of capturing and/or reporting on REGN clinical trial applications
- Engage and oversee any vendor engaged to help collect, enter and/or maintain relevant information regarding Clinical Trial Applications (CTA) via the EMA CTIS database
Document Management:
· Under supervision perform basic document management tasks including file transfer, storage, tracking, and archival of Regulatory Guidelines
- Develop a familiarity with current global regulatory submission standards.
Compliance with Parexel Standards:
· Complies with required training curriculum
- Completes timesheets accurately as required
- Submits expense reports as required
- Updates CV as required
- Maintains effective relationships with other platform lines, Business Units/Research Units, and enabling lines that facilitate effective portfolio delivery
Skills:
· Working knowledge of the clinical drug development process, ICH/GCP and regulatory guidelines/directives
- Strong familiarity with EUCTD/R and Federal Code of Regulations
- Familiarity with Veeva Vault Clinical for CTMS and eTMF use
- Demonstrates ability to prioritize and manage multiple projects simultaneously
- Demonstrates effective problem solving and decision-making skills
- Interpersonal, collaboration and stakeholder management skills
- Good communication (written/verbal)
- Highly organized, detail oriented
- Ability to synthesize information and demonstrate strategic thinking
- Self-motivated, flexible, able to follow through in a fast-paced environment, ability to meet deadlines under pressure
- Computer skills with competency in MS suite a plus
- May require up to 25% travel
Knowledge and Experience:
Minimum 1-3 years of relevant/clinical essential document review experience
Education:
· Bachelor’s degree
Originally posted on Himalayas