Clinical Assessment Data Operations Associate

Responsibilities

• Support the implementation and maintenance of eCOA/ePRO and IRT systems across clinical studies
• Assist in reviewing study specifications, system documentation, and performing user acceptance testing (UAT)
• Track study timelines and deliverables related to eCOA/ePRO and IRT implementation and decommissioning
• Coordinate routine meetings with vendors and internal stakeholders and document meeting minutes
• Monitor study issues and assist with follow-up and resolution
• Serve as an operational contact for eCOA/ePRO and IRT vendors
• Support reconciliation activities between eCOA, IRT, and the clinical database
• Maintain Trial Master File (TMF/eTMF) documentation and ensure inspection readiness
• Partner with Clinical Data Management, Biostatistics, and Clinical Operations to support study execution

Requirements

• Bachelor's degree in Life Sciences, Computer Science, Health Sciences, or a related field
• 2–5 years of experience in clinical research, clinical data management, or clinical trial operations
• Experience supporting Phase I–III clinical trials
• Familiarity with patient-reported outcomes (PRO) or clinician-reported outcomes (ClinRO)
• Experience working with CROs or clinical technology vendors
• Familiarity with eCOA/IRT systems (e.g., Suvoda) and EDC systems (e.g., Medidata Rave, Veeva CDMS)
• Working knowledge of GCP and ICH guidelines

About the Company

Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases, aiming to achieve high rates of complete disease clearance with infrequent dosing.