高级临床数据经理
Senior Clinical Data Manager
BeOne持续以快速的速度增长，为有经验的专业人士提供具有挑战性和令人兴奋的机会。在考虑候选人时，我们寻找的是高度积极、善于合作，并且最重要的是，对抗击癌症充满热情的科研和商业专业人士。
职位概述：
高级临床数据经理负责分配和/或推动临床试验数据管理活动的所有方面，从试验启动到数据库锁定，并负责所有数据评审人员交付成果的质量。
岗位核心职责：
• 为指定的临床研究与研究负责人数据经理密切合作。
• 根据公司程序文件和研究特定的数据管理（DM）文件执行数据清理/核对工作。
• 管理指定临床研究中的问题。
• 生成并交付报告给研究团队成员。
• 支持外部数据核对，以及严重不良事件的核对。
• 确保实验室数据（如适用）及相应的实验室正常范围得到评审和核对。
• 支持数据管理文档的创建和维护（例如，数据管理计划、电子病例报告表（eCRF）填写指南）。
• 协助确保DM文档按照公司的标准操作规程（SOP）和工作指令（WI）归档。
• 在必要时支持eCRF和编辑检查规范的开发，以支持协议要求的数据收集和分析。
• 可能与数据库构建者紧密合作，在临床数据库构建和eCRF、编辑检查和报告编程期间提供支持。
• 参与临床数据库构建和修改的用户验收测试（UAT）活动。
• 参与数据传输和程序化报告输出的UAT活动。
• 协助管理指定临床研究的临床数据库中的站点和用户。
• 在经理监督下，可能领导一个或多个I期至II期研究。
• 将有机会主导所有与数据评审相关的活动。这还包括在出现数据问题时识别并上报给数据管理团队。
• 可能与供应商（如中心实验室）合作，以支持时间表和与数据相关的交付成果。
• 可能帮助根据指标数据、审计报告和其他项目团队成员的反馈，识别和解决研究中的操作性问题、障碍和瓶颈。
查看英文原文
BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
General Description:
The Senior Clinical Data Manager’s role is responsible for assigning and/or driving all aspects of the clinical trial
data management activities, from study start up through database lock, and is responsible for the quality of all
data reviewers’ deliverables.
Essential Functions of the job:
• Supports and works closely with study lead data manager(s) for assigned clinical studies.
• Performs data cleaning/reconciliation activities as specified in company procedural documents and studyspecific
Data Management (DM) documents.
• Manages queries on assigned clinical studies.
• Generates and delivers reports to study team members.
• Supports external data reconciliation, in addition to serious adverse event reconciliation.
• Ensures laboratory data, if applicable, and associated lab normal ranges are reviewed and reconciled.
• Supports the creation and maintenance of DM documentation (e.g., Data Management Plans, eCRF
Completion Guidelines).
• Helps to ensure DM documents are filed per company Standard Operating Procedures (SOP) and Work
Instructions (WI).
• Supports eCRF and edit check specifications development as necessary to support data collection and
analyses required by the protocol.
• May work closely with database builders during clinical database build and programming of eCRF, edit
checks, and reports.
• Participates in User Acceptance Testing (UAT) activities for clinical database build and modifications.
• Participates in UAT activities for data transfers and programmed report outputs.
• Assists with Site and User management in clinical database of assigned clinical studies.
• May lead one or more Phase I to Phase II studies under supervision of manager.
• Will have the opportunity to drive all data review related activities. This will also include identifying and
escalating potential data issues to the Data Management Team when issues arise.
• May work with vendors such as central laboratories in support of timelines and data-related deliverables.
• May help identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based
on metrics data, audit reports, and input from other project team members. This also includes mentoring
other study team members when opportunities arise.
• May help train other personnel on eCRFs and EDC.
• May help support development and maintenance of SOP and WI related to data management activities.
• Other duties as assigned.
Supervisory Responsibilities:
NA
Computer Skills:
• Proficient computer skills, including Microsoft Office applications
• Working knowledge of at least one EDC system, Medidata Rave is preferred
Other Qualifications:
• 5+ years of experience in clinical data management in the pharmaceutical/biotechnology industry
• Oncology experience preferred
• Ability to work in cross-functional team-oriented environments
• Understanding for ICH and regulatory environment as it pertains to data management and good
understanding of data management and phases of clinical trials
• Have a good understanding of data management knowledge and understands the phases of clinical trials
• Strong communications skills and capable of solving issues independently. • Strong project management
skills
• Excellent written, verbal and organizational skills
• Good interpersonal skills and have the capability to lead studies DR(s) and prioritize DM activities.
• Must be detail-oriented
Travel:
Travel may be required as per business need, ability to travel domestically and internationally.
Education Required:
Bachelor’s degree or equivalent in a health-related field
preferred
Global Competencies
When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
- Fosters Teamwork
- Provides and Solicits Honest and Actionable Feedback
- Self-Awareness
- Acts Inclusively
- Demonstrates Initiative
- Entrepreneurial Mindset
- Continuous Learning
- Embraces Change
- Results-Oriented
- Analytical Thinking/Data Analysis
- Financial Excellence
- Communicates with Clarity
Salary Range: $108,700.00 - $143,700.00 annuallyBeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact .
Originally posted on Himalayas