Clinical Data Manager
Core
Lead end-to-end clinical data management for companion diagnostic (CDx) studies to ensure timely, accurate, and compliant data delivery for global regulatory submissions.
Role type
Senior Clinical Data Manager (Companion Diagnostics)
Builds
Submission-ready clinical data packages and datasets for FDA (PMA, 510(k), NDA/BLA) and EU (IVDR) regulatory filings.
Domain
Biopharma / In-vitro Diagnostics (IVD) / Companion Diagnostics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> clinical data packages & datasets
Required skills
CDISC standards (SDTM, ADaM, CDASH, Define.xml), EDC/CRF system design & validation, risk-based data management, regulatory compliance (GCP, ICH), data integrity monitoring, cross-functional collaboration
Preferred skills
Oncology clinical trials, biomarker-driven studies, precision medicine, cancer diagnostics, pathology knowledge
Technologies
Medidata Rave, Veeva CDMS/EDC, Oracle Inform, REDCap
Responsibilities
Lead EDC/CRF system design, validation, UAT, and database lock; Collaborate with Biostatistics to develop submission-ready SDTM and ADaM datasets; Author and maintain data management documentation (SOPs, DMPs, CRFs); Perform quality control checks and identify data integrity issues; Act as SME during audits and regulatory inspections; Manage data transfer specifications and liaise with pharmaceutical partners.
Seniority
Senior, hands-on IC
