Clinical Assessment Data Operations Associate
Oruka TherapeuticsAbout the role
About Us:
Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit www.orukatx.com
As we build our core team, we're seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger. Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture.
Job Title: Clinical Assessment Data Operations Associate
Location: Remote or Hybrid if located within commutable distance of Waltham, MA or Menlo Park, CA
Position Summary
The Clinical Assessment Data Operations Associate supports the Associate Director, Clinical Assessment Data Operations in the planning, implementation, and maintenance of clinical assessment technologies, including eCOA/ePRO and IRT systems, across Oruka Therapeutics' clinical development programs. The Associate is responsible for coordinating day-to-day operational activities, tracking study deliverables, supporting vendor interactions, and ensuring high-quality documentation while maintaining compliance with applicable regulatory requirements, GCP, and Oruka SOPs.
This role works closely with Clinical Data Management, Biostatistics, Clinical Operations, Medical, Regulatory, Outsourcing, and external vendors to support successful execution of clinical studies.
Key Responsibilities
Study Support
- 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.
- Support in coordinating routine meetings with vendors and internal stakeholders and document meeting minutes and action items.
- Monitor study issues and assist with follow-up and resolution.
Vendor & System Coordination
- Serve as an operational contact for eCOA/ePRO and IRT vendors for assigned activities.
- Track vendor deliverables, documentation, and project milestones.
- Assist with management of licensing activities and study-specific documentation.
- Support governance meeting preparation by compiling metrics and reviewing presentation materials.
Clinical Trial Support
- Assist with site support in issue resolution and documenting and routing system-related questions to appropriate stakeholders.
- Coordinate collection and tracking of post-production system changes.
- Support reconciliation activities between eCOA, IRT, and the clinical database.
- Participate in database lock preparation activities related to IRT/eCOA data.
Documentation & Quality
- Maintain Trial Master File (TMF/eTMF) documentation related to IRT, eCOA and Data Management as necessary.
- Ensure required study documentation is complete, current, and inspection-ready.
- Assist in preparation for audits and regulatory inspections.
- Support development and maintenance of departmental templates, work instructions, and SOPs.
Cross-functional Collaboration
- Partner with Clinical Data Management, Biostatistics, Clinical Operations, Medical, Regulatory, Outsourcing and Programming to support study execution.
- Participate in study team meetings and provide operational updates.
- Contribute to process improvement initiatives and lessons learned activities.
Qualifications
Education
- Bachelor's degree, preferably in Life Sciences, Computer Science, Health Sciences, or a related field.
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