临床数据经理
Clinical Data Manager
致力于精准医疗和推动医疗行业发展的你，是否感到兴奋？
近年来底层技术的进展终于使人工智能能够以有意义的方式影响临床护理。Tempus的专有平台连接整个现实世界证据生态系统，为医生提供实时、可操作的见解，提供关于正确患者在正确时间接受正确治疗的关键信息。
首席临床数据经理将参与并领导支持客户研究的数据管理活动，涵盖临床药物开发的所有阶段。他们将与跨职能团队合作，主导数据管理计划。
理想的候选人具有在全球CRO环境中工作的经验，对数据管理最佳实践、良好临床实践和适用的监管要求有深入理解。该候选人应直接参与过数据管理部门的建设。具有所有临床试验阶段的经验，尤其是肿瘤学和I期试验经验，至关重要。
工作职责：
• 支持临床研究的数据管理活动，包括：
o 通过领导跨职能团队审查eCRF内容，推动eCRF开发。
o 数据库构建活动，包括审查编辑检查规范和执行用户验收测试。
o 通过跟踪研究指标和针对性的数据审查，监督供应商的数据收集、编码和清理。
o 监督数据库锁定活动，并最终归档研究数据。
• 与内部和外部合作伙伴协作，包括生物统计学、统计编程、临床运营、医学、质量保证、药物安全和药物警戒；CRO、中心和本地实验室以及其他供应商。
• 建立跨职能的内部数据审查计划，协调数据切割/传输，并进行数据审查。
• 审查CRO的数据管理计划、CRF填写指南、编辑检查规范、外部数据传输规范和其他研究文档。
• 代表数据管理，在内部跨职能团队会议和与外部供应商的会议中有效沟通需求、策略、时间表和交付成果。
• 参与制定与公司目标一致的时间表，并确保所有交付成果和里程碑得以实现。
• 审查临床方案/修正案、临床研究报告、
查看英文原文
Passionate about precision medicine and advancing the healthcare industry?
Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.
The Lead Clinical Data Manager will contribute and lead data management activities in support of client
studies across all stages of clinical drug development. They will be responsible for working with cross
functional teams leading the data management initiatives.
The ideal candidate has experience working in a global CRO setting with an excellent understanding of
data management best practices, good clinical practice, and applicable regulatory requirements. This
candidate will have direct experience developing a data management department. Experience with all
phases of clinical trials, with strong oncology and phase 1 experience, is critical.
Job Responsibilities:
• Contribute to data management activities in support of clinical studies, including:
o eCRF development by leading cross-functional reviews of eCRF content.
o Database build activities, including review of edit check specifications and performance
of user acceptance testing.
o Monitoring data collection, coding, and cleaning by vendors through tracking of study
metrics and targeted data reviews.
o Oversight of database lock activities and ultimate archiving of study data.
• Collaborate with internal and external partners, including Biostatistics, Statistical Programming,
Clinical Operations, Medical, Quality Assurance, Drug Safety and Pharmacovigilance; CROs,
central and local laboratories, and other vendors.
• Establish cross-functional, internal data review plans, coordinate data cuts/transfers, and
conduct data reviews.
• Review CRO data management plans, CRF completion guidelines, edit check specifications,
external data transfer specifications and other study documentation.
• Represent data management and effectively communicate requirements, strategy, timelines
and deliverables at internal cross-functional team meetings and meetings with external vendors.
• Participate in the drafting and/or review of timelines consistent with company goals and ensure
all deliverables and milestones are met.
• Review clinical protocols/amendments, clinical study reports, statistical analysis plans, etc.
• Support GCP inspection readiness.
• Demonstrate clear alignment with company Core Values including, Commitment to People,
Innovation and Discovery, Sense of Urgency, Open Culture and Passion for Excellence.
• Performs other duties as assigned.
• May involve travel.
Demonstration of Tempus Compass Values:
Consistently strives to demonstrate the following Highline Sciences values:
• Recognizes that the team is always stronger than the individual.
• Seeks to inspire others by demonstrating consistently strong performance.
• Treats people with respect regardless of role or point of view.
• Listens well and seek to understand before reacting.
• Provides candid, helpful, and timely feedback to colleagues.
• Demonstrates curiosity about and contributes effectively to areas outside of their specialty.
• Keeps the bigger picture in mind when making decisions.
• Never stops learning.
• Questions assumptions and offers suggestions for improvement.
• Focuses on results rather than process and seeks to minimize complexity when process is required.
• Identifies and addresses root causes, not symptoms.
• Demonstrates poise in stressful situations.
• Strives to always do the right thing.
• Questions actions that are incongruent with Highline Sciences values.
Minimum Qualifications:
• BS/BA in scientific discipline, MS or equivalent preferred, with at least 8 years related experience in
a CRO/pharmaceutical/biologics/biotechnology company.
• Study/Vendor oversight experience.
• Experience with global studies, utilizing an outsourced CRO model.
• Expert knowledge of Data Management processes, efficient design/build of an EDC data
management system and other Clinical Trial/Data Management Systems.
• Knowledge and understanding of regulations and industry-adopted data standards, such as CDISC
SDTM and CDASH.
• Experience working with EDC data management systems.
• Understanding of ICH GCP as well as general knowledge of industry practices and standards.
• Knowledge and understanding of regulatory requirements and expectations for clinical data systems
including 21 CFR Part 11.
• Highly motivated and flexible, with excellent organizational and time management skills
• Ability to work independently and as part of a multi-disciplinary team.
• Proficient in Microsoft Word and Excel.
Preferred Qualifications:
• Experience working with Medidata Rave EDC.
• Experience using standardized medical terminology, including MedDRA and WHODrug.
• Prior experience working for both a Sponsor company and a CRO
• Early phase clinical trial experience
Personal Skills:
• Excellent interpersonal and communications skills (verbal and written), as well as problem solving
and organization skills.
• Proven ability to work independently.
• Self-motivated, pro-active, and resourceful.
• Strong ability to manage managers and/or individual contributors.
• Outstanding organizational skills.
• Excellent analytical and problem-solving skills.
• Excellent communication skills with a diplomatic approach including the ability to work with various.
personalities and perspectives.
• Excellent ability to lead cross-functional initiatives related to Data Management.
• Demonstrated proactive thought process to minimize and mitigate risk independently.
• Demonstrated ability to conduct root cause analysis cross-functionally in business problem solving
and process improvement development.
• Excellent presentation skills: internal, external.
The expected salary range may vary for other locations. Actual salary may vary based on qualifications and experience. Tempus offers a full range of benefits, which may include incentive compensation, restricted stock units, medical and other benefits depending on the position.
We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Originally posted on Himalayas