Subject Matter Expert / Product Manager (Clinical Data & Regulatory Standards)
Our client develops secure, standards-compliant digital health solutions that empower researchers and public health institutions to advance evidence-based medicine. The company builds scalable research infrastructures, supports international standards such as FHIR, OMOP, and CDISC, and collaborates with some of the world’s leading clinical institutions.
What We’re Looking For:
- 5+ years of experience as a Product Owner / Product Manager / Clinical Product Specialist, ideally in clinical research, EDC/eCRF, CTMS, or healthcare data platforms
Hands-on experience with eCRF design (form definition, edit checks, CRF lifecycle, study build) using EDC platforms such as Medidata Rave, Veeva Vault CDMS, OpenClinica, REDCap, Castor, or equivalent
Solid working knowledge of CDISC SDTM (and ideally CDASH, ADaM, Define-XML, ODM-XML) and how clinical data flows from collection to submission
Familiarity with clinical research operations: protocols, study lifecycle, data management plans, monitoring, and the role of CROs and sponsors
Strong understanding of regulatory and quality frameworks relevant to clinical data: GCP/ICH E6, 21 CFR Part 11, GDPR/HIPAA, with awareness of EMA/FDA submission expectations
Experience with Agile development methodologies and tools (Jira, Confluence, etc.)
Excellent communication and stakeholder management skills, with the ability to bridge technical and clinical/regulatory audiences
Professional written and spoken English
Act as the domain expert on clinical data capture and regulatory data standards — bringing eCRF design experience and a working knowledge of CDISC SDTM (and ideally CDASH, ADaM, ODM-XML) into product discussions
Prepare detailed product requirements, user stories, and acceptance criteria for specific features, working under the supervision of the Senior / Lead Product Manager
Translate complex clinical and regulatory standards into product specifications that engineering, design, and data teams can implement with confidence
Manage and groom the backlog for the assigned feature areas, ensuring alignment with the broader product roadmap and strategic objectives set by the Lead Product Manager
Facilitate sprint planning, backlog refinement, and release cycles using Agile methodologies.
Collaborate with clinical researchers, study managers, data managers, and biostatisticians to gather requirements, validate prototypes, and refine workflows
Ensure features meet regulatory expectations (GDPR, HIPAA, GCP/ICH E6, 21 CFR Part 11 where applicable) and support seamless data standardization, traceability, and interoperability
Define and monitor product metrics for the assigned feature areas, providing regular updates to stakeholders
Would be a plus
- Bachelor's or Master's degree in Life Sciences, Health Informatics, Biostatistics, Computer Science, Bioinformatics, or a related field
- Spoken and written German