Clinical Assessment Data Operations Associate

Oruka Therapeutics

Clinical data operations associate supporting eCOA/ePRO and IRT systems at Oruka Therapeutics, a developer of biologic treatments for chronic skin diseases. Coordinating vendors, study deliverables, documentation, reconciliation, and clinical trial operations.

Posted 8/14/2026full-timeRemote • California, Massachusetts • 🇺🇸 United StatesJuniorMid-Level💰 $104,000 - $125,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in managing eCOA/ePRO and IRT systems within clinical development, ensuring compliance with GCP and ICH guidelines while effectively coordinating project deliverables and stakeholder communication.

Highest-signal resume keywords

Clinical Research ExperienceECOA/IRT Systems FamiliarityProject Coordination SkillsRegulatory Compliance KnowledgeMicrosoft Office Proficiency

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Data ManagementUser Acceptance TestingStudy Specification ReviewDatabase Lock PreparationDocumentation Management

Soft Skills

Strong Organizational SkillsExcellent Communication SkillsInterpersonal SkillsCollaboration SkillsAbility to Manage Multiple Priorities

Tools & Technologies

SuvodaMedidata RaveVeeva CDMSMicrosoft ExcelMicrosoft PowerPoint

Industry Keywords

Phase I–III Clinical TrialsPatient-Reported OutcomesClinician-Reported OutcomesGCPICH Guidelines

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Support the planning, implementation, and maintenance of eCOA/ePRO and IRT systems across clinical development programs
Coordinate day-to-day operational activities and track study deliverables
Review study specifications and system documentation and perform user acceptance testing
Track study timelines and deliverables related to system implementation and decommissioning
Coordinate routine vendor and stakeholder meetings and document minutes and action items
Monitor study issues and assist with follow-up and resolution
Serve as an operational contact for eCOA/ePRO and IRT vendors
Track vendor deliverables, documentation, and project milestones
Assist with licensing activities and study-specific documentation
Prepare governance meetings by compiling metrics and reviewing presentation materials
Support site issue resolution and route system-related questions
Coordinate post-production system changes
Support reconciliation between eCOA, IRT, and the clinical database
Participate in database lock preparation related to IRT/eCOA data
Maintain TMF/eTMF documentation and ensure it is inspection-ready
Assist with audits and regulatory inspections
Support departmental templates, work instructions, and SOPs
Partner with Clinical Data Management, Biostatistics, Clinical Operations, Medical, Regulatory, Outsourcing, Programming, and external vendors
Participate in study team meetings and provide operational updates
Contribute to process improvement and lessons learned activities

Requirements

What you’ll need

Bachelor's degree, preferably 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 supporting Phase I–III clinical trials
Familiarity with patient-reported outcomes, clinician-reported outcomes, or other electronic clinical outcome assessments
Experience working with CROs or clinical technology vendors
Familiarity with eCOA/IRT systems, such as Suvoda
Familiarity with EDC systems, such as Medidata Rave and Veeva CDMS
Proficiency with Microsoft Office Suite, including Excel, Word, PowerPoint, and Teams
Strong organizational and project coordination skills
Ability to manage multiple priorities in a fast-paced environment
Excellent written and verbal communication skills
Strong interpersonal and collaboration skills
Ability to work independently while escalating issues appropriately
Working knowledge of GCP, ICH guidelines, and clinical trial processes

Benefits

Comp & perks

Competitive base salary
Equity
Performance-related bonus opportunity
Competitive salary and benefits package
Supportive and inclusive team environment
Opportunities for professional growth and development
Startup culture where work can directly impact bringing new medicines to patients