Subject Matter Expert / Product Manager (Clinical Data & Regulatory Standards)

Binariks is looking for an experienced Subject Matter Expert / Product Manager with deep domain knowledge in clinical data and regulatory standards (eCRF, CDISC SDTM) to embed directly within the client's product organization. Working under the supervision of a Senior or Lead Product Manager, you will help translate complex clinical and regulatory requirements into clear, actionable product specifications for specific features of a research software platform.
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

Your Responsibilities:

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