samedi GmbH
Senior Product Manager(m/w/x)
Full-timeWith HomeofficeSenior
Berlin
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DAData4Life
Senior Product Manager Digital Health Studies(m/w/x)
Berlin, Potsdam
Full-timeWith Home OfficeSenior
Nejo AI Summary
Evolving D4L Collect platform for digital health studies, focusing on a Patient Registry solution with 21 CFR Part 11 audit trails and eConsent. 3+ years of regulated digital health product management experience required. Nonprofit work with flexible hours and 30 days vacation.
Requirements
- 3+ years product craft foundation (discovery, roadmap, prioritization, PRDs) in agile environment
- 3+ years product management experience in B2B or regulated digital health solutions
- 1+ years defining and shipping clinical research software (EDC, ePRO/eCOA, eConsent, patient registry, sensor-based study platforms)
- Hands-on experience shipping under GCP/ICH E6(R3), 21 CFR Part 11, EU Annex 11
- Computer system validation and audit-ready release management
- Working fluency in clinical data standards (CDISC SDTM, CDASH)
- Working understanding of HIPAA and GDPR in clinical trials/real-world data
- Bachelor's degree in relevant field or equivalent practical experience
- Fluent English
- German at B2 level or third language is a plus
Tasks
- Drive the evolution of D4L Collect
- Shape the platform's roadmap for a Patient Registry solution
- Develop a regulatory-grade product with 21 CFR Part 11 audit trails
- Implement eConsent with e-signatures
- Treat compliance as a design constraint
- Extend capture and connect functionality
- Add support for new sensors and wearable devices
- Integrate EHR data via HL7 FHIR
- Expand the standard questionnaire library, including SDoH
- Ensure all data types are research-ready and interoperable
- Enable clinical trial standards through import and export
- Import data from REDCap and other EDC/CTMS solutions
- Export data to CDISC SDTM
- Implement validation and certification for D4L Collect
- Advocate for the user within the team
- Build deep relationships with D4L Collect users
- Prioritize user feedback in development conversations
Work Experience
- 2 - 5 years
Education
- Bachelor's degree
Languages
- English – Fluent
- German – Advanced
Tools & Technologies
- CDISC SDTM
- CDISC CDASH
- GCP
- ICH E6(R3)
- 21 CFR Part 11
- EU Annex 11
- HIPAA
- GDPR
Benefits
Job Security
- Permanent contract
Social Impact
- Nonprofit work
- DEI group participation
Purpose-Driven Work
- Socially impactful projects
- Employee-driven initiatives
Flexible Working
- Flexible working hours
- Mobile work option
More Vacation Days
- 30 days of paid vacation
Healthcare & Fitness
- Support for private healthcare
Sustainability Focus
- Support for sustainable mobility
- Climate group participation
Other Benefits
- Support for applicants with disabilities
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Data4Life and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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DAData4Life
Senior Product Manager Digital Health Studies(m/w/x)
Berlin, Potsdam
Full-timeWith Home OfficeSenior
Nejo AI Summary
Evolving D4L Collect platform for digital health studies, focusing on a Patient Registry solution with 21 CFR Part 11 audit trails and eConsent. 3+ years of regulated digital health product management experience required. Nonprofit work with flexible hours and 30 days vacation.
Requirements
- 3+ years product craft foundation (discovery, roadmap, prioritization, PRDs) in agile environment
- 3+ years product management experience in B2B or regulated digital health solutions
- 1+ years defining and shipping clinical research software (EDC, ePRO/eCOA, eConsent, patient registry, sensor-based study platforms)
- Hands-on experience shipping under GCP/ICH E6(R3), 21 CFR Part 11, EU Annex 11
- Computer system validation and audit-ready release management
- Working fluency in clinical data standards (CDISC SDTM, CDASH)
- Working understanding of HIPAA and GDPR in clinical trials/real-world data
- Bachelor's degree in relevant field or equivalent practical experience
- Fluent English
- German at B2 level or third language is a plus
Tasks
- Drive the evolution of D4L Collect
- Shape the platform's roadmap for a Patient Registry solution
- Develop a regulatory-grade product with 21 CFR Part 11 audit trails
- Implement eConsent with e-signatures
- Treat compliance as a design constraint
- Extend capture and connect functionality
- Add support for new sensors and wearable devices
- Integrate EHR data via HL7 FHIR
- Expand the standard questionnaire library, including SDoH
- Ensure all data types are research-ready and interoperable
- Enable clinical trial standards through import and export
- Import data from REDCap and other EDC/CTMS solutions
- Export data to CDISC SDTM
- Implement validation and certification for D4L Collect
- Advocate for the user within the team
- Build deep relationships with D4L Collect users
- Prioritize user feedback in development conversations
Work Experience
- 2 - 5 years
Education
- Bachelor's degree
Languages
- English – Fluent
- German – Advanced
Tools & Technologies
- CDISC SDTM
- CDISC CDASH
- GCP
- ICH E6(R3)
- 21 CFR Part 11
- EU Annex 11
- HIPAA
- GDPR
Benefits
Job Security
- Permanent contract
Social Impact
- Nonprofit work
- DEI group participation
Purpose-Driven Work
- Socially impactful projects
- Employee-driven initiatives
Flexible Working
- Flexible working hours
- Mobile work option
More Vacation Days
- 30 days of paid vacation
Healthcare & Fitness
- Support for private healthcare
Sustainability Focus
- Support for sustainable mobility
- Climate group participation
Other Benefits
- Support for applicants with disabilities
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Data4Life and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
Data4Life
Industry
Healthcare
Description
Data4Life ist eine Non-Profit-Organisation, die Gesundheitsforschung digitalisiert und Gesundheitsdaten sicher zur Verfügung stellt.
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