Clinical Assessment Data Operations Associate

Remotedxb

Dubai

On-site

AED 167,000 - 234,000

Full time

8 days ago

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Job summary

Oruka Therapeutics in Dubai is seeking a clinical operations professional to support the implementation and maintenance of eCOA/ePRO and IRT systems across trials. You will review study specifications, assist in UAT, track timelines, and coordinate meetings with vendors and stakeholders.

Ideal candidates have a life sciences-related degree, 2–5 years in clinical research or data management, and familiarity with PRO/ClinRO, CROs, and leading EDC and eCOA tools.

Qualifications

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

Responsibilities

  • Support implementation and maintenance of eCOA/ePRO and IRT systems.
  • Assist in reviewing study specifications, system documentation, and performing 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 TMF/eTMF documentation and ensure inspection readiness.
  • Partner with Clinical Data Management, Biostatistics, and Clinical Operations to support study execution.

Skills

Clinical operations
Data management
ECOA/ePRO
IRT systems
GCP/ICH
Vendor management

Education

Bachelor's degree in Life Sciences/Computer Science/Health Sciences

Tools

Suvoda
Medidata Rave
Veeva CDMS

Job description

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.

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