обновлено 3 дня назад
Senior Product Manager (Clinical Data)
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Senior Product Manager (Clinical Data): Building D4L Collect into a regulatory-grade EDC platform for digital health studies, patient registries, and clinical trials with an accent on clinical data workflows, EHR integrations, and compliance. Focus on translating CDISC, 21 CFR Part 11, and EU Annex 11 requirements into software capabilities, leading engineering delivery, and connecting clinical data to downstream real-world evidence analytics.
Location: Berlin/Potsdam, Germany; regular presence required in the Potsdam and/or Berlin office. Flexible working models include the option to work from home.
Company
develops digital health products designed to support healthcare research, clinical studies, patient registries, and real-world evidence generation.
What you will do
- Lead the evolution of D4L Collect from a sensor-native registry platform into a regulatory-grade Electronic Data Capture platform.
- Own product strategy and a scalable SaaS roadmap across registry, clinical trial, and integrated trial platform phases.
- Ship Epic EHR integrations using SMART on FHIR and Epic Interconnect, along with REDCap import and export.
- Translate CDISC, 21 CFR Part 11, and EU Annex 11 requirements into product requirements for e-signatures, audit logs, query workflows, and data locking.
- Partner with investigators, study coordinators, clinical data managers, engineering, design, scientific, and regulatory teams to shape end-to-end workflows.
- Define clinical data flows into Data2Evidence for downstream real-world evidence generation.
Requirements
- 5+ years of experience as a software product manager in a B2B SaaS environment, including writing PRDs, managing backlogs, and shipping software with engineering teams.
- 2+ years of direct experience defining and launching clinical data software such as EDC, ePRO/eCOA, eConsent, or patient registry products.
- Practical experience turning CDISC SDTM/CDASH, 21 CFR Part 11, and EU Annex 11 requirements into shipped functionality.
- Bachelor's degree in Computer Science, (Bio)Medical Engineering, Health Informatics, or equivalent practical software product experience.
- Fluent English is required.
- Regular presence in the Berlin and/or Potsdam office is required.
Nice to have
- Experience integrating wearable, sensor, or medical device APIs into data collection platforms.
- Working knowledge of HL7 FHIR and SMART on FHIR-based EHR integration patterns.
- Working proficiency in German at B2 level or higher.
Culture & Benefits
- High personal responsibility and creative freedom.
- Socially impactful projects in the healthcare sector.
- Collaboration with research, technology, and healthcare partners.
- Interdisciplinary and international work across Potsdam, Berlin, and Singapore.
- Permanent employment contract with 30 days of vacation.
- Private supplementary health insurance and a public transport ticket.
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