临床数据经理 / 高级临床数据经理（合同）
Clinical Data Manager / Senior Clinical Data Manager (Contract)
DELFI Diagnostics, Inc. (DELFI Diagnostics) 正在开发下一代基于血液的检测方法，这些方法可靠、易获取，并为癌症检测提供一种新方式。利用全基因组测序数据的先进机器学习方法，DELFI（"DNA EvaLuation of Fragments for early Interception"）平台旨在解决高负担的健康挑战。DELFI Diagnostics 优先考虑具有全球拯救生命潜力的解决方案，包括历史上未被充分服务的人群。DELFI Diagnostics 的平台依赖于片段组学——这一发现表明癌细胞比正常细胞更混乱，当它们死亡时，会留下游离 DNA（cfDNA）片段的特征性模式和特征。FirstLook Lung 是 DELFI Diagnostics 针对符合肺癌筛查条件的个体开发的首个实验室自研筛查测试，可以成为常规血液检查的一部分。FirstLook Lung 使用数百万个数据点，可靠地识别可能通过低剂量 CT 检测到癌症的个体，包括早期疾病，其阴性预测值为 99.8%。该测试尚未经过 FDA 的审查或批准。
在我们致力于彻底改善健康结果的热情追求中，我们通过以下方式服务人类：
- 以科学为引领，以务实为根基：我们始终确保质量、透明度和严谨性，推动改变生命的科学。我们深思熟虑地探索，聪明地实验，坚定地实现影响。
- 与所有人共同构建：我们拥抱多样化的背景，共同创新和实现目标。我们不仅仅是在打造一个产品——我们的目标是为所有人改变癌症的路径——无论地理或社会经济阶层。
- 把“我们”置于“我”之上：我们是高绩效人士的家园。通过团队合作，我们构建集体智慧。当我们服务的对象和与我们一同服务的人获胜时，我们每个人都会获胜。我们在旅程的每一步都展现出同理心、谦逊和正直。
关于职位
DELFI 正在推进 DELFI-L201（CASCADE）IVD 临床验证研究的一系列关键里程碑。我们正在寻找一位经验丰富的合同临床数据经理（CDM），以在此关键时期提供补充的 CDM 能力。
你将负责
核心 CDM 执行
- 在研究 EDC 和数据收集系统中执行持续的数据清理和问题管理
- 进行数据审查、差异管理、医学编码支持（如需要）和对账活动，包括
查看英文原文
DELFI Diagnostics, Inc. (DELFI Diagnostics) is developing next-generation, blood-based tests that are reliable, accessible and deliver a new way to help detect cancer. Employing advanced machine-learning methods to whole-genome sequencing data, the DELFI ("DNA EvaLuation of Fragments for early Interception") platform is built to address the highest-burden health challenges. DELFI Diagnostics prioritizes solutions that have the potential to save lives on a global scale, including for historically underserved populations. DELFI Diagnostics’ platform relies on fragmentomics – the discovery that cancer cells are more chaotic than normal cells and, when they die, leave behind tell-tale patterns and characteristics of cell-free DNA (cfDNA) fragments. FirstLook Lung, for individuals eligible for lung cancer screening, is DELFI Diagnostics’ first laboratory-developed screening test and can be part of routine blood work. FirstLook Lung uses millions of data points to reliably identify individuals who may have cancer detected through low-dose CT, including early stage disease with a negative predictive value of 99.8 percent. This test has not been cleared or approved by the FDA.
In our passionate pursuit to radically improve health outcomes, we serve humanity when we:
- Lead with Science, Anchor in Pragmatism: We pioneer life-changing science by ensuring quality, transparency, and rigor at all times. We explore thoughtfully, experiment smartly, and deliver impact with conviction.
- Build With & For All: We embrace diverse backgrounds to innovate and achieve together. We are not just building a product - we aim to disrupt the path of cancer for all - no matter geography or socioeconomic class
- Put We over I: We are a home for high-performing people. Through teamwork, we build collective intelligence. Each of us wins when those we serve and those who serve with us--win. We show up with empathy, humility, and integrity at every step of the journey.
About the role
DELFI is approaching a series of time-critical milestones for the DELFI-L201 (CASCADE) IVD Clinical Validation study. We are seeking an experienced contract Clinical Data Manager (CDM) to provide supplemental CDM capacity through this critical period.
What you'll do
Core CDM Execution
- Perform ongoing data cleaning and query management in the study EDC and data collection systems
- Conduct data review, discrepancy management, medical coding support (as needed), and reconciliation activities, including sample-to-clinical data reconciliation
- Work from data quality report output produced by DELFI's data team, translating findings into queries and resolutions
- Support CRF freeze/lock readiness and database lock preparation
- Participate in study team meetings and provide brief weekly written status summaries covering work completed and risks/blockers
Specification Development
- Develop and finalize Derived Variable (DV) specifications and requirements documentation using DELFI templates and conventions
- Support Table, Figure, and Listing (TFL) specifications, including review against the Statistical Analysis Plan (SAP)
- Provide limited statistical programming or implementation support for derived variables and TFL-related datasets, as skills allow
What you'll bring
Required (both levels)
- 3–5+ years of hands-on clinical data management experience in a pharmaceutical, medical device/diagnostic company, or CRO
- Direct experience supporting database lock activities in clinical trials
- Proficiency with Medidata Rave EDC
- Ability to work independently with minimal ramp-up, and excellent organizational, written, and verbal communication skills
Required (Senior level)
- 5+ years of CDM experience, including experience authoring DV and/or TFL specifications
- Ability to read and interpret a Statistical Analysis Plan and translate it into specification documents
Preferred
- Experience in oncology, diagnostics, or IVD/regulated device studies
- R programming experience
- Familiarity with leveraging AI tools (e.g., Claude Code, Gemini) to streamline clinical data management workflows, data review, or scripting tasks
- Familiarity with Clario or comparable imaging/adjudication data platforms
An equal opportunity employer
We are an equal opportunity employer and value diversity at our company. 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