Subject Matter Expert / Product Manager (Clinical Data)

TL;DR

Subject Matter Expert / Product Manager (Clinical Data): Translating complex clinical and regulatory requirements into actionable product specifications for a research software platform with an accent on eCRF design and CDISC SDTM standards. Focus on bridging technical and clinical audiences to ensure regulatory compliance (GCP, HIPAA, GDPR) and seamless data interoperability.

Location: Remote (Global)

Company

hirify.global is an outsourcing company that embeds domain experts directly into client product organizations to build scalable digital health solutions.

What you will do

• Act as the domain expert for clinical data capture and regulatory standards (eCRF, CDISC SDTM) during product discussions.
• Prepare detailed product requirements, user stories, and acceptance criteria for specific features.
• Translate complex regulatory frameworks into technical specifications for engineering, design, and data teams.
• Manage and groom the product backlog to align with the broader roadmap and strategic objectives.
• Collaborate with clinical researchers, data managers, and biostatisticians to validate prototypes and refine workflows.
• Ensure features comply with GDPR, HIPAA, and GCP/ICH E6 regulatory expectations.

Requirements

• 5+ years of experience as a Product Owner, Product Manager, or Clinical Product Specialist in clinical research or healthcare data platforms.
• Hands-on experience with eCRF design using platforms such as Medidata Rave, Veeva Vault CDMS, OpenClinica, or REDCap.
• Solid working knowledge of CDISC SDTM (and ideally CDASH, ADaM, Define-XML, ODM-XML).
• Strong understanding of regulatory frameworks: GCP/ICH E6, 21 CFR Part 11, GDPR, and HIPAA.
• Experience with Agile development methodologies and tools like Jira and Confluence.
• Professional written and spoken English.

Nice to have

• Bachelor's or Master's degree in Life Sciences, Health Informatics, Biostatistics, Computer Science, or Bioinformatics.
• Proficiency in spoken and written German.

Culture & Benefits

• Work from anywhere policy.
• 18 days of paid annual leave and 10 sick leaves.
• Medical care and health check-ups.
• Professional development through Tech Talks, certifications, and conference support.
• Corporate currency and internal team activities.
• Additional days off for special occasions.