Clinical Assessment Data Operations Associate

<div class="content-intro"><p><strong>About Us:</strong><strong>&nbsp;</strong></p> <p>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 <a href="http://www.orukatx.com">www.orukatx.com</a></p> <p>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.&nbsp; Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture. &nbsp;</p></div><p><span style="font-size: 12pt;"><strong>Job Title: </strong>Clinical Assessment Data Operations Associate</span></p> <p><span style="font-size: 12pt;"><strong>Location: </strong>Remote or&nbsp; Hybrid if located within commutable distance of Waltham, MA or Menlo Park, CA</span></p> <h2><span style="font-size: 12pt;">Position Summary</span></h2> <p><span style="font-size: 12pt;">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.</span><br><br><span style="font-size: 12pt;">This role works closely with Clinical Data Management, Biostatistics, Clinical Operations, Medical, Regulatory, Outsourcing, and external vendors to support successful execution of clinical studies.</span></p> <h2><span style="font-size: 12pt;">Key Responsibilities</span></h2> <h3><span style="font-size: 12pt;">Study Support</span></h3> <ul> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Support the implementation and maintenance of eCOA/ePRO and IRT systems across clinical studies.</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Assist in reviewing study specifications, system documentation, and performing user acceptance testing (UAT).</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Track study timelines and deliverables related to eCOA/ePRO and IRT implementation and decommissioning.</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Support in coordinating routine meetings with vendors and internal stakeholders and document meeting minutes and action items.</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Monitor study issues and assist with follow-up and resolution.</span></li> </ul> <h3><span style="font-size: 12pt;">Vendor &amp; System Coordination</span></h3> <ul> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Serve as an operational contact for eCOA/ePRO and IRT vendors for assigned activities.</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Track vendor deliverables, documentation, and project milestones.</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Assist with management of licensing activities and study-specific documentation.</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Support governance meeting preparation by compiling metrics and reviewing presentation materials.</span></li> </ul> <h3><span style="font-size: 12pt;">Clinical Trial Support</span></h3> <ul> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Assist with site support in issue resolution and documenting and routing system-related questions to appropriate stakeholders.</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Coordinate collection and tracking of post-production system changes.</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Support reconciliation activities between eCOA, IRT, and the clinical database.</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Participate in database lock preparation activities related to IRT/eCOA data.</span></li> </ul> <h3><span style="font-size: 12pt;">Documentation &amp; Quality</span></h3> <ul> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Maintain Trial Master File (TMF/eTMF) documentation related to IRT, eCOA and Data Management as necessary.</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Ensure required study documentation is complete, current, and inspection-ready.</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Assist in preparation for audits and regulatory inspections.</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Support development and maintenance of departmental templates, work instructions, and SOPs.</span></li> </ul> <h3><span style="font-size: 12pt;">Cross-functional Collaboration</span></h3> <ul> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Partner with Clinical Data Management, Biostatistics, Clinical Operations, Medical, Regulatory, Outsourcing and Programming to support study execution.</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Participate in study team meetings and provide operational updates.</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Contribute to process improvement initiatives and lessons learned activities.</span></li> </ul> <h2><span style="font-size: 12pt;">Qualifications</span></h2> <h3><span style="font-size: 12pt;">Education</span></h3> <ul> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Bachelor's degree, preferably in Life Sciences, Computer Science, Health Sciences, or a related field.</span></li> </ul> <h3><span style="font-size: 12pt;">Experience</span></h3> <ul> <li style="font-size: 12pt;"><span style="font-size: 12pt;">2–5 years of experience in clinical research, clinical data management, or clinical trial operations supporting Phase I–III clinical trials.</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Familiarity with patient-reported outcomes (PRO), clinician-reported outcomes (ClinRO), or other electronic clinical outcome assessments.</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Experience working with CROs or clinical technology vendors.</span></li> </ul> <h3><span style="font-size: 12pt;">Technical Skills</span></h3> <ul> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Familiarity with eCOA/IRT systems (e.g. Suvoda), and EDC systems (e.g., Medidata Rave, Veeva CDMS).</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Proficiency with Microsoft Office Suite (Excel, Word, PowerPoint, Teams).</span></li> </ul> <h3><span style="font-size: 12pt;">Competencies</span></h3> <ul> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Strong organizational and project coordination skills.</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Ability to manage multiple priorities in a fast-paced environment.</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Excellent written and verbal communication skills.</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Strong interpersonal and collaboration skills.</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Ability to work independently while escalating issues appropriately.</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">Working knowledge of GCP, ICH guidelines, and clinical trial processes.<strong>&nbsp; &nbsp; &nbsp; &nbsp;</strong></span></li> </ul> <p><span style="font-size: 12pt;"><strong>&nbsp; &nbsp;</strong><strong>Compensation:</strong></span></p> <ul> <li style="font-size: 12pt;"><span style="font-size: 12pt;">An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.</span></li> <li style="font-size: 12pt;"><span style="font-size: 12pt;">The anticipated salary range for candidates, who will work in remotely or hybrid if located within commutable distance of Waltham, MA or Menlo Park, CA, is $104,000 to $125,000 . The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.</span></li> </ul> <p><span style="font-size: 12pt;">We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.</span></p><div class="content-pay-transparency"><div class="pay-input"><div class="title">Salary Range for the Role</div><div class="pay-range"><span>$104,000</span><span class="divider">&mdash;</span><span>$125,000 USD</span></div></div></div><div class="content-conclusion"><p><strong>What We Offer:</strong></p> <ul> <li>A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.</li> <li>Competitive salary and benefits package.</li> <li>A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.</li> <li>Opportunities for professional growth and development.</li> </ul></div>