Product Manager - Digital Health Studies (f/m/x)

RxREVU, Inc.; Berlin; Hybrid; EUR 90.000 - 120.000; Vollzeit

Benefits dieser Stelle

Private health insurance

Public transport ticket

Zusammenfassung

Data4Life seeks a Senior Product Manager to lead D4L Collect's evolution into a modern, regulatory-grade EDC platform, bridging registries and trials. You will own the product strategy and a scalable SaaS roadmap, writing PRDs and guiding engineering sprints in close collaboration with regulatory and clinical teams.

Based in Berlin/Potsdam with a permanent contract, you will work across three locations and contribute to a diverse, international team, with flexible working options and strong

Qualifikationen

• 5+ years as a Software Product Manager with backlogs, PRDs and shipping features in a B2B SaaS environment.
• 2+ years defining and shipping Clinical Data Software (EDC, ePRO/eCOA, or patient registry software).
• Working fluency in CDISC (SDTM/CDASH), 21 CFR Part 11 and EU Annex 11 requirements.
• Bachelor-level technical degree in CS/biomedical field or equivalent practical software product experience.
• Fluent in English.

Aufgaben

• Lead evolution from a sensor-native registry to a regulatory-grade EDC platform, starting with Mount Sinai deployment.
• Write PRDs, lead agile sprints and validate decisions through user discovery.
• Collaborate with investigators, study coordinators and data managers to shape end-to-end workflows.
• Define data flows into Data2Evidence to accelerate Real-World Evidence generation.

Kenntnisse

5+ years Software Product Manager

Clinical Data Software ownership

CDISC/21 CFR Part 11 expertise

Bachelor's degree in CS/BioMed Eng

English fluency

Ausbildung

Bachelor's degree in Computer Science, (Bio)Medical Engineering, Health Informatics

Tools

HL7 FHIR / SMART on FHIR (integration patterns)

Jobbeschreibung

Hi there!

Our goal at Data4Life is to make the world a healthier place. Our product team makes sure we move toward that goal with focus, rigor and speed -translating research ambition into products that generate real impact in healthcare, in Germany and beyond.

D4L Collect is our sensor data collection platform for digital health studies -a unified solution where researchers can simultaneously capture patient-reported and multimodal sensor data, using FHIR, in a GDPR-compliant manner.

We're looking for a Senior Product Manager to lead D4L Collect's further development into a modern, sensor-native EDC platform bridging academic registries and clinical trials by introducing Electronic Data Capture (EDC) capabilities. You'll partner with the Lead Product Manager and Project Managers already on the team, and work closely with our engineering, product design, scientific and regulatory teams to make D4L Collect the platform of choice for digital health studies, patient registries and regulated trials. The position is full-time, based in Berlin / Potsdam, with a permanent contract.

Your future role

You'll lead D4L Collect's evolution from a sensor-native registry platform into a modern, regulatory-grade EDC platform -starting with our flagship deployment at Mount Sinai for the Mount Sinai Million Health Discoveries Program, where you'll own the product strategy and build a scalable SaaS roadmap. This is a hands‑on product role: you write PRDs, lead agile engineering sprints, and validate decisions through user discovery -building the software that powers clinical trials, in close partnership with the people who run them.

You'll own the roadmap across three phases:

1. Modern Registry Platform: a sensor-native solution for academic & real-world registries with EHR integration, seamless REDCap project import/export, eConsent, and immutable audit trails
2. Regulatory-Grade EDC for GCP Trials: expanding to eCRFs, query management, data lock, CDISC standards (CDASH/SDTM), and 21 CFR Part 11 / EU Annex 11 compliance
3. Integrated Trial Platform: full CTMS workflows and decentralized trial capabilities feeding directly into Data2Evidence for downstream analytics

Concretely, you will:

• Ship native Epic EHR integrations (SMART on FHIR, Epic Interconnect) and REDCap import/export so study teams can migrate without manual re-entry
• Translate CDISC (SDTM/CDASH), 21 CFR Part 11 and EU Annex 11 requirements into clear engineering PRDs (e-signatures, immutable audit logs, query workflows, data locking)
• Partner with site investigators, study coordinators and clinical data managers as co-design partners to shape end-to-end workflows
• Define how captured clinical data flows into Data2Evidence to accelerate downstream Real-World Evidence (RWE) generation

What you need to succeed

Must-Haves:

• 5+ years as a Software Product Manager: demonstrated experience writing PRDs, managing backlogs, and shipping features with software engineering teams in a B2B SaaS environment
• 2+ years directly defining and shipping Clinical Data Software: direct experience defining and launching EDC, ePRO / eCOA, eConsent, or patient registry software as a software product owner
• Working fluency in clinical standards: demonstrated track record of turning CDISC (SDTM, CDASH), 21 CFR Part 11, and EU Annex 11 requirements into shipped software functionality
• Technical Foundation: Bachelor's degree in Computer Science, (Bio)Medical Engineering, Health Informatics, or equivalent practical software product experience
• Languages: fluent in English

Nice-to-Haves

• Hands‑on experience integrating wearable, sensor, or medical device APIs into data collection platforms
• Working knowledge of HL7 FHIR / SMART on FHIR-based EHR integration patterns
• Working proficiency in German (B2+)

Why you will love working with us

• High level of personal responsibility and creative freedom
• Work on socially impactful projects in the healthcare sector
• Collaboration with leading partners from research, technology, and healthcare
• A diverse, interdisciplinary, and international team working across three locations (Potsdam, Berlin, and Singapore)
• Flexible working models with the option to work from home
• Permanent employment contract with 30 days of vacation
• Attractive employee benefits, e.g. private supplementary health insurance, public transport ticket

Good to know

• We especially welcome applicants from the LGBTQI+ community, people with a migration background, people of color, and individuals with neurodiversity, disabilities, or chronic illnesses to the team.
• If you need support or special assistance during the application or interview process due to a disability, please feel free to let us know and we are happy to accommodate you as much as possible.
• Please enclose your complete documents (CV, Github Account, Work sample) with your application.
• For this position it is important that you are able to regularly be present in our Potsdam and/or Berlin office.

About us

Data4Life is a nonprofit organization with the vision of making the world a healthier place. With an international team, we work together on the mission to digitize health research. By linking technology and research, we make health data available to research in a comprehensive, digital and secure way. Our interdisciplinary team in Potsdam, Berlin and Singapore brings together experts from fields such as product development, digital engineering, data security and science. Data4Life was founded in 2017 and is funded by the Hasso Plattner Foundation.

We care about Diversity

Many different lives, careers, and development paths lead to Data4Life. We welcome experts from a wide range of backgrounds and experiences to our international team, offering everyone equal opportunities to be themselves and develop to the best of their abilities. Diversity, equality, and inclusion are not just nice words at Data4Life - we put them into practice in all of our activities and projects, striving to incorporate them in our everyday lives. For this reason, we signed the Charta der Vielfalt (Diversity Charter) in 2022.