Clinical Assessment Data Operations Associate
Remotedxb
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.
#J-18808-LjbffrVacancy posted 3 days ago
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