临床评估技术运营经理
Manager, Clinical Assessment Technologies Operations
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安于现状的人铺就的。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力去实现的人所打造的。
我们是Worldwide Clinical Trials,我们是一支超过3,500名专家、有远见的思考者、梦想家和实干家组成的全球团队,我们正以最好的方式改变世界对CRO的认知。
我们的使命是每天以热情和目标工作,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
我们相信每个人都在为患者及其护理者带来巨大影响中扮演着重要角色。从我们亲力亲为、平易近人的领导,到我们紧密协作、互相支持的团队,我们致力于让来自不同背景和经验的专业人士取得成功。我们优先打造一个多元且包容的环境,持续促进协作与创造力。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,并被激励每天发挥最佳水平。加入我们吧!
在Worldwide Operations Manager 的职责
Operations Manager 对Worldwide Clinical Trials, Inc.(Worldwide)相关的操作工作负主要责任,包括评审员选拔、评审员认证/资格审核、评审员培训内容、量表获取、监督维护以及工作表/原始文档管理。Operations Manager 负责确保所有分配的项目按时进行,并且符合标准操作规程(SOP)、国际协调会议/良好临床实践(ICH/GCP)和监管指南。Operations Manager 在临床评估技术(CAT)运营总监的指导下工作。
你将负责的工作
- 协调评审员经验资格文件的完整性,并向发起方和研究团队传达收集结果
- 开发针对特定研究的评审员培训网络门户,并根据研究时间表确保其准备就绪
- 协调研究人员会议及相关CAT材料的后勤事务;经理可能会参加此类会议
- 组织及时完成教学培训演示文稿的编辑和格式化
- 通过获取量表许可证,负责量表和研究原始工作表的管理
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 Operations Manager does at Worldwide
The Operations Manager has primary responsibility for overseeing the operational work related to rater selection, rater certification/qualification, rater training content, scale acquisition, surveillance maintenance, and workbook/source document management for Worldwide Clinical Trials, Inc. (Worldwide). The Operations Manager is responsible for ensuring all assigned projects are conducted in a timely fashion and in a manner compliant with Standard Operating Procedures (SOPs), International Council for Harmonization/Good Clinical Practice (ICH/GCP), and regulatory guidelines. The Operations Manager works under the direction of the Operations Director, Clinical Assessment Technologies (CAT).
What you will do
- Coordinate completeness of rater experience qualification documents and communicate collection results to the Sponsor and study team
- Develop study-specific rater training web portals and ensure readiness based on study timelines
- Coordinate logistical matters of the Investigators’ Meetings and associated CAT materials; manager may attend such meetings
- Organize the timely completion of editing and formatting of didactic training presentations
- Oversee scale and study source workbook management by obtaining scale licenses, translations, regulatory authorizations, and Sponsor approvals
- Oversee data surveillance methodology maintenance by tracking and reconciling incoming source documentation and providing reports to the study team and Sponsor
- Provide necessary CAT data to ensure comprehensiveness of CAT’s Final Study Report
- Oversee archiving of all CAT study documents
- Consult on rater training and data surveillance plans to ensure documents represent Sponsor and protocol specifications
- Other Clinical Assessment responsibilities
- May develop and present at Sponsor Kick-Off Meetings regarding CAT operations work
- Work with the Operations Director and Worldwide Clinical Trials study team to ensure study budgetary demands are met
- Manage Operations staff, as assigned
- 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
- Highly organized, detail-oriented, and service-oriented
- Excellent planning, managing, monitoring, scheduling, and critiquing skills
- Excellent at meeting timelines consistently and effectively working under pressure
- Continuously open to constructive, developmental feedback
- Strong writing and verbal communication skills to clearly and concisely present information
- Strong interpersonal skills in a fast-paced, deadline-oriented, and changing environment
- Strong ability to handle multiple tasks and administrative details in a fast-paced and constantly changing environment
- Strong self-motivation skills
- Strong ability to work in teams
- Excellent proficiency in all Microsoft Office applications, including Microsoft Word, Excel, Adobe, and PowerPoint
Your experience
- Bachelor’s degree in Life Science preferred
- Two to four years of experience working in clinical trials
- At least two years of experience managing team members or leading a team. In lieu of people management experience, the individual must demonstrate a strong ability to lead, understand policies and procedures, financial and leadership principles, possess excellent time management and project management skills, and communicate effectively
- Demonstrable knowledge of operational aspects regarding Phase I-IV clinical research trials and ample knowledge of Standard Operating Procedures (SOPs), International Council for Harmonization/Good Clinical Practice (ICH/GCP), and regulatory guidelines
- Competency working with data and numbers
- Fluency in English (will be required to write, speak, and understand English to conduct day-to-day business)
- The role requires domestic and international travel to attend key meetings. The global nature of the position may also require the incumbent to manage their time flexibly on occasion to be responsive to stakeholders in different time zones
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 - $90,000.00 - $178,000.00The 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