Clinical Assessment Data Operations Associate

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🔥 0 minutes ago

🏄 California, Massachusetts – Remote

🏄 California – Remote 🍂 Massachusetts – Remote

💵 $104k - $125k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

⚙️ Operations

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Oruka Therapeutics

WebsiteLinkedInAll Job Openings

11 - 50 employees

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Oruka Therapeutics is a biopharmaceutical company dedicated to developing novel biologics for the treatment of chronic skin diseases, particularly plaque psoriasis and related conditions. The team at Oruka consists of experienced biopharma professionals focused on creating best-in-class monoclonal antibodies designed to improve treatment outcomes and enhance patient experiences. Their innovative approach aims for complete disease clearance with minimal dosing, advancing the standard of care for dermatologic and inflammatory disorders.

📋 Description

• 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

• 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

• 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