高级临床数据经理
Senior Clinical Data Manager
我们是谁
我们是一家全球性的中型CRO,不断突破界限,创新并创造,因为治愈世界上最顽固疾病的道路不是由那些保守行事的人铺就的。它是由那些采取开创性、创造性方法并以高质量和卓越执行它们的人所构建的。
我们是Worldwide Clinical Trials,我们是一个由3500多名专家、聪明的思考者、梦想家和实干家组成的全球团队,我们一起正在以最好的方式改变世界对CRO的体验。
我们的使命是每天充满激情和目标地工作,改善人们的生活,我们正在寻找同样重视这一追求的人。
为什么选择Worldwide
我们认为每个人都在为患者及其护理者带来巨大影响方面发挥着重要作用。从我们亲力亲为、易于接触的领导,到我们紧密协作且互相支持的团队,我们致力于让来自各种背景和经验的专业人士取得成功。我们优先打造一个多元化和包容的环境,持续促进协作和创造力。我们自豪地成为这样一个职场,在这里,人们可以做真实的自己,并每天被激励做出最好的工作。加入我们吧!
Senior Clinical Data Manager在Worldwide的工作内容
监督、领导、管理并提供技术专长于指定项目,以确保它们高效、准确且及时地执行,满足申办方的满意度。
你将负责
- 独立自主地领导多个复杂全球项目的数据管理服务(启动、执行和收尾)
- 确保分配适当的资源以按时且在预算内完成所有数据管理(DM)活动
- 准备数据管理试验文档,包括数据管理计划(DMPs)、数据库规范、编辑检查规范、CRF填写指南(CCGs)和数据传输协议(DTAs)
- 确保有效执行用户验收测试(UAT)
- 编写外部供应商对编程核对输出的核对规范(例如,严重不良事件、交互式响应技术(IRT)、中心实验室)
- 监督数据清理活动
- 生成指标以监控试验活动的进展
- 确保所有数据库锁定活动按时完成
- 在内部和外部研究会议电话中代表Worldwide Clinical Trials的数据管理团队,包括提供输入
- 监控项目范围、预算
查看英文原文
Who we are
We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.
We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.
Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.
Why Worldwide
We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!
What the Senior Clinical Data Manager does at Worldwide
Oversee, lead, manage, and provide technical expertise within assigned projects to ensure they are executed in an efficient, accurate, and timely manner to the Sponsor’s satisfaction.
What you will do
- Provide fully independent and autonomous leadership of data management services (start-up, conduct, and closeout) across multiple complex global projects/programs
- Ensure appropriate resources are allocated to complete all data management (DM) activities on time and within budget
- Prepare DM trial documentation, including Data Management Plans (DMPs), Database Specifications, Edit Check Specifications, CRF Completion Guidelines (CCGs), and Data Transfer Agreements (DTAs)
- Ensure effective User Acceptance Testing (UAT) is performed
- Write external vendor reconciliation specifications for programming reconciliation outputs (e.g., Serious Adverse Events, Interactive Response Technology (IRT), Central Laboratory)
- Oversee data cleaning activities
- Produce metrics to monitor progress of trial activities
- Ensure all database lock activities are completed on time
- Represent Worldwide Clinical Trials Data Management at both internal and external study meeting calls, including providing input
- Monitor project scope, budgets, and risks and alert DM Management of any concerns
- Liaise with DM Management at regular intervals to discuss progress and any outstanding issues (e.g., during Project Review Meetings)
- Collaborate with internal Worldwide Clinical Trials departments working on the same project
- Provide feedback on process improvements to DM Management and/or Subject Matter Experts (SMEs)
- Participate in and lead process reviews
- Provide training, support, and mentorship to other members of the DM department
- Participate, as necessary, in sponsor audits, regulatory authority inspections, and other third-party meetings
- Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
What you bring to the role
- Excellent attention to detail
- Excellent written and verbal communication skills
- Strong knowledge of data management best practices and technologies as applied to clinical trials
- Excellent communication and interpersonal skills to collaborate with cross-functional internal and external teams
- Strong understanding of clinical trial processes, protocol documents (protocols, Statistical Analysis Plans (SAPs), Case Report Forms (CRFs), study reports), and related procedures
- Strong analytical and problem-solving skills
- Independent and autonomous project oversight skills
Your experience
- Bachelor’s degree or higher in biomedical sciences, life sciences, computer science, or a related discipline, or equivalent relevant experience
- Minimum of 5 years of experience in clinical data management or a related role within the pharmaceutical, biotechnology, or medical device industries
- Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.
At Worldwide Clinical Trials, we are committed to fostering an inclusive and equitable workplace by providing transparent compensation.
The salary range for this position is annually (For hourly paid positions, the stated salary range reflects hourly rates):
United States of America - $79,000.00 - $157,000.00The salary range provided is intended to give candidates an understanding of potential earnings. Compensation will fall within the provided range, and it not a guarantee of exact salary. The final salary will be determined based on relevant experience, performance, education, and internal equity. In addition to base salary, we offer a competitive benefits package depending on location. We ensure pay equity and transparency and comply with all applicable labor laws. Salary information will be discussed during the interview process, and we encourage candidates to inquire about compensation at any stage.
We love knowing that someone is going to have a better life because of the work we do.
To view our other roles, check out our careers page at Discover a world of difference at Worldwide! For more information on Worldwide, visit or connect with us on LinkedIn.
Originally posted on Himalayas