Clinical Data Team Lead - Remote U.S
职位标题：临床数据团队领导 - 远程美国工作地点：拉利，北卡罗来纳州，美国工作场所类型：远程工作合同类型：全日制工作资深级别：工作时间表标准 （月-周五）环境条件办公室工作内容 加入我们作为临床数据组负责人 在创新前沿产生影响。我们成功支持了50家顶尖的药品公司和750多家生物技术，在过去5年中跨越100多个国家进行2,700项临床试验。作为我们的专业团队的一部分，你将有机会确保对组织绩效真正差异的运营卓越性。作为临床数据团队负责人，你将担任一个或多个项目的主要数据管理员，或者为主管数据管理人员提供支持。你可以在高级团队成员的支持下领导个人限量/复杂性研究的所有数据管理活动。此外，你将成为所有数据管理研究活动的部门间和客户联络者。你将做什么：· 将项目协议的相关组件应用于日常任务并指导他人如何适用他们的日常任务。•根据需要与项目负责人和/或客户联系，并在研究中的所有数据管理 (DM) 活动中与管理层沟通。•制定和维护数据管理项目文件；按照记录的 CDM 指导方针进行独立审查数据管理成果。•为 DM 项目人员提供研究具体培训。•定期向管理层，项目领导者和/或客户提交特定项目的状态报告。监测研究标准。•可协助竞标准备并/或代表竞标辩护会议中参与业务发展活动。•协助项目预测时间和确定资源需求，并识别出潜在的范围外活动，为项目负责人和管理人员提供帮助，以及协助合同修改过程。•指导年级工作人员完成研究中的所有相关任务。•协助分配项目的行政和财务管理。独立有效地执行所有赋予数据管理活动，以关注质量。教育和经验要求：•学士学位或相当及相关的正式学术/职业资格 •前期
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Job Title: Clinical Data Team Lead - Remote U.S
Job Location: Raleigh, North Carolina, USA
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level:
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
Join Us as a Clinical Data Team Lead – Make an Impact at the Forefront of Innovation. We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.
As part of our expert team, you’ll have the opportunity to ensure operational excellence that makes a real difference in organizational performance. As a Clinical Data Team Lead, you will act as the lead data manager for one or more projects or provide support to the lead data manager. You may lead all data management activities for individual, limited volume/complexity studies with support from senior team members. Additionally, you will act as an interdepartmental and client liaison for all data management study activities.
What You’ll Do:
- Applies relevant components of the project protocol to daily tasks and directs others on how to apply to their daily tasks.
- •Acts as a liaison to the Project Lead and/or client as required and communicates with management regarding all data management (DM) activities within their studies.
- •Develops and maintains data management project documentation files; performs independent reviews of data management deliverables following documented CDM guidelines.
- •Develops and delivers study specific training for DM project staff.
- •Produces project-specific status reports for management, Project Lead and/or clients on a regular basis. Monitors study metrics.
- •May participate in business development activities by assisting with bid preparation and/or representing data management at bid defense meetings, where required.
- •Assists with project forecasting of hours and identification of resource requirements and identifies potential out of scope activities to Project Lead and management and assists with the Contract Modification process.
- •Mentors junior level staff on all associated tasks within a study.
- •Assists with the administrative and financial management of allocated projects. Performs all assigned data management activities independently and efficiently, with attention to quality.
Education and Experience Requirements:
•Bachelor's degree or equivalent and relevant formal academic / vocational qualification
•Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years). Prior experience must reflect lead(end-to-end) responsibilities.
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
•Ability to effectively apply knowledge and skills in a highly organized fashion while adhering to regulatory guidelines, SOPs and client expectations
•Ability to use interactive computer programs
•Good written/ verbal communication skills with a strong command of English language and grammar; good organizational, analytical/problem solving skills and attention to detail
•Ability to work productively with minimal supervision
•Ability to maintain a high degree of confidentiality with clinical data and client's proprietary data
•Strong customer focus and excellent interpersonal skills
•Proven flexibility and adaptability
•Ability to work in a team environment and independently as needed
•Ability to train and direct study team
•Ability to set and meet timelines or be able to recognize and schedule changes in response to project demands
Working Conditions and Environment:
•Work is performed in an office environment with exposure to electrical office equipment.
•Occasional drives to site locations with occasional travel both domestic and international.
Why Join Us?
When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.
Apply today to help us deliver tomorrow’s breakthroughs.
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