> Markdown version of [/jobs/ext/2515601-senior-data-manager-cro-oversight-early-phase](https://www.wearedevelopers.com/jobs/ext/2515601-senior-data-manager-cro-oversight-early-phase). Every page supports `.md` or `Accept: text/markdown`. Links point to the HTML versions so they work for humans too. Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Senior Data Manager, CRO Oversight, Early Phase... - **Company:** Eliassen Group - **Location:** Sacramento, CA, United States (Remote available) - **Experience:** Expert - **Salary:** $166,400.0 - $187,200.0 - **Contract:** Contract - **Skills:** Biometrics, Clinical Data Management, Clinical Data Repository, Databases, Data Transmissions, Oracle (Applications), Information Technology, Real Time Data, Data Management, Veeva - **Published:** August 2, 2026 - **Apply:** https://www.juju.com/job/00000000gldr5n ## About the Role _Due to client requirements, applicants must be willing and able to work on a w2 basis. For our w2 consultants, we offer a great benefits package that includes Medical, Dental, and Vision benefits, 401k with company matching, and life insurance._, + Bachelor's degree in Life Sciences, Computer Science, Biostatistics, Data Science, or related field. + 8-12 years of data management experience, with the majority on the sponsor side. + Minimum 3+ years leading Phase 1 studies, including first-in-human healthy volunteer SAD/MAD and Phase 1b/2 patient studies as Lead Data Manager. + Sponsor-side oversight of CRO and specialty vendor data management, including specification review, deliverable and timeline oversight, and escalation of underperformance. + Hands-on Medidata Rave experience, including study configuration, edit check specification, and Rave reporting. Working knowledge of other EDC platforms such as Veeva or Oracle InForm is a plus. + Familiarity with CDISC standards (SDTM), data reconciliation processes, coding dictionaries, and database lock activities. + Solid understanding of ICH-GCP, FDA, EMA, and other applicable clinical data management regulations and guidance. + Excellent analytical, organizational, and communication skills with strong attention to detail and the ability to collaborate across cross-functional scientific and operational teams. + Nice to have: Experience working alongside a Biometrics vendor responsible for biostatistical activities. Education Requirements: Bachelor's degree in Life Sciences, Computer Science, Biostatistics, Data Science, or related field. _Recruitment Transparency Notice_ ## Description Our client is seeking a Senior Data Manager to provide operational support across multiple early-stage clinical studies in a wide variety of therapeutic areas. This individual will partner with cross-functional study teams and external CROs to ensure the timely delivery of high-quality clinical data that supports informed decision-making throughout Phase 1 first-in-human and Phase 1b/2 patient studies. This is a highly operational role requiring the ability to manage multiple programs simultaneously and serve as a trusted partner to study teams, while maintaining flexibility in a fast-paced, resource-efficient environment. This individual will report into our client's Associate Director of Data Management & Technology., + Review and contribute to study-specific data management plans, edit check specifications, data review plans, CRF/eCRF design, database specifications, and data transfer agreements. + Participate in protocol review to ensure data collection strategies support study objectives while minimizing operational complexity. + Serve as sponsor-side oversight of CRO and specialty vendor data management deliverables, including scope and specifications, timelines, quality, metrics review, and issue escalation, while retaining accountability for partner-executed work. + Own database build oversight, user acceptance testing (UAT), database lock activities, and study closeout. + Drive ongoing data review, query management, reconciliation activities including safety, laboratory, and external vendor data, and issue resolution throughout study conduct. + Deliver clean, near-real-time data on compressed timelines to support dose-escalation decisions, safety review committee meetings, DLT assessment, and interim data cutoffs. + Monitor data quality metrics and proactively identify risks that may impact study timelines, database quality, or regulatory readiness. + Support the preparation for interim analyses, regulatory submissions, and clinical study reports by ensuring timely, high-quality datasets. + Serve as the Medidata user administrator at the URL level, including assigning access to CRO study builders, coders, and data managers at the CRO. + Evaluate and recommend improvements to clinical data management systems, technologies, and workflows as appropriate. + Contribute to inspection readiness activities and ensure compliance with applicable GCP, ICH, FDA, EMA, and other regulatory requirements. ## Related Videos - [Beyond Gut Feelings: The Rise of Data-Driven HR](https://www.wearedevelopers.com/videos/1326-beyond-gut-feelings-the-rise-of-data-driven-hr) - [Kubernetes and Microservices with Multi-Model Databases](https://www.wearedevelopers.com/videos/382-kubernetes-and-microservices-with-multi-model-databases) - [Biometric Phone Chargers, $40m Domain Names & AI Movies Winning Awards - Peter Kröner](https://www.wearedevelopers.com/videos/1810-biometric-phone-chargers-40m-domain-names-ai-movies-winning-awards-peter-kroner) - [Demografie nutzen um jedem Bewerber das passende Angebot zu machen!](https://www.wearedevelopers.com/videos/836-demografie-nutzen-um-jedem-bewerber-das-passende-angebot-zu-machen) - [Fault Tolerance and Consistency at Scale: Harnessing the Power of Distributed SQL Databases](https://www.wearedevelopers.com/videos/1146-fault-tolerance-and-consistency-at-scale-harnessing-the-power-of-distributed-sql-databases) - [WeAreDevelopers LIVE - What Development and Tattoos Have in Common and more](https://www.wearedevelopers.com/videos/1380-wearedevelopers-live-what-development-and-tattoos-have-in-common-and-more) ## Related Articles - [Data Analyst Salary in the UK](https://www.wearedevelopers.com/magazine/278-data-analyst-salary-in-the-uk) - [Résumé-Driven Development: How IT trends affect the job market for software developers](https://www.wearedevelopers.com/magazine/59-resume-driven-development-how-it-trends-affect-the-job-market-for-software-developers) - [Fully Remote Software Engineer Jobs](https://www.wearedevelopers.com/magazine/447-fully-remote-software-engineer-jobs) - [The Biggest German Tech Companies](https://www.wearedevelopers.com/magazine/424-the-biggest-german-tech-companies) - [Data Engineer Salary UK](https://www.wearedevelopers.com/magazine/253-data-engineer-salary-uk) - [Highest Paying Tech Companies for Developers](https://www.wearedevelopers.com/magazine/220-highest-paying-tech-companies-for-developers)