{"id":1980232,"url":"https://alion.io/job/oruka-manager-clinical-data-management","title":"Manager, Clinical Data Management","company":{"id":688198,"name":"Oruka Therapeutics","domain":"oruka.com","url":"https://alion.io/company/oruka","size_band":"1-10","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":{"grade":"A","score":92,"open_postings":8,"ghost_share":0,"stale_share":0.125,"repost_share":0,"time_to_fill_p50_days":65,"computed_at":"2026-10-29T05:49:05Z"}},"role":"Science & Research","role_family":"Science & Research","seniority":"staff","employment_type":null,"work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":[],"countries":[],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":146000,"max":161000,"currency":"USD","period":"year","gross":null,"usd_annual":161000},"salary_estimate":null,"experience_years_min":10,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CDISC","optional":false},{"name":"GCP","optional":false},{"name":"Good Clinical Practice","optional":false},{"name":"Medidata Rave","optional":false},{"name":"Oracle","optional":false},{"name":"Veeva","optional":false}],"status":"live","first_seen_at":"2026-10-06T21:02:51Z","employer_posted_date":"2026-10-06","last_verified_at":"2026-10-29T14:27:29Z","board_verified":true,"closed_at":null,"days_open":22,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":22},"description":"About Us: \nOruka 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\nAs 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. \nJob Title: Manager of Clinical Data Management \nLocation: Remote OR Hybrid in Waltham, MA office, will be required 3 days/week if located near office. \nRole Overview: \nOruka Therapeutics is seeking an experienced and highly motivated Manager, Clinical Data Management, to support our expanding clinical development portfolio. This position is responsible for leading and overseeing all clinical data management activities across assigned clinical studies, ensuring the delivery of high-quality, reliable clinical data in compliance with applicable regulatory requirements, ICH-GCP guidelines, and Oruka Therapeutics Standard Operating Procedures (SOPs).\nThe Manager will serve as the lead Clinical Data Manager for approximately three to four clinical studies across various stages of the study lifecycle, including study start-up, conduct, database lock, and closeout. This individual will collaborate closely with cross-functional teams, CRO partners, and external vendors to ensure the successful execution of data management deliverables while maintaining quality, timelines, and budget.\nThis position reports to the Senior Director, Data Management.\nKey Responsibilities: \nClinical Data Management Leadership\nServe as the lead Clinical Data Manager for assigned Phase I-IV clinical trials.\nProvide strategic oversight of all CRO data management activities from database start-up through database lock, clinical study report (CSR), and regulatory submission.\nServe as the primary Data Management representative and point of contact for CROs, third-party vendors, and internal cross-functional study teams.\nDevelop and manage study timelines in collaboration with internal teams and CRO partners to ensure all data management milestones and deliverables are achieved.\nDatabase Development & Study Start-Up\nOversee the design, development, testing, and validation of clinical databases, including User Requirements, electronic Case Report Forms (eCRFs), edit checks, data validation specifications, and User Acceptance Testing (UAT).\nReview and approve key data management documentation, including:\nData Management Plans (DMPs)\nCase Report Forms (CRFs)\nCRF Completion Guidelines\nManual Data Review Guidelines\nEdit Check Specifications\nData Validation Specifications\nOther study-specific data management documentation\nParticipate in the development and review of specifications for related clinical technologies, including eCOA/ePRO and IRT/IVRS systems.\nData Review & Database Lock\nOversee all study-related data cleaning activities, including reconciliation of external data sources such as laboratory, ECG, imaging, eCOA/ePRO, and other vendor data.\nEnsure clinical and external data meet quality standards required for interim analyses, database freezes, unlocks, and final database lock.\nConduct ongoing internal review of study data throughout study conduct to proactively identify and resolve data quality issues.\nMaintain the internal Data Review Log and collaborate with CROs to ensure timely resolution of all outstanding queries and data issues.\nPartner with Biometrics, Statistical Programming, and Biostatistics to develop oversight listings, patient profiles, reports, and programming checks that support efficient data review.\nVendor Oversight & Financial Management\nProvide oversight of Data Management CROs and external vendors to ensure high-quality deliverables, adherence to timelines, and compliance with contractual obligations.\nReview Statements of Work (SOWs), Requests for Proposals (RFPs), budgets, and Change Orders for completeness, accuracy, and alignment with study objectives.\nReview vendor metrics, reconciliation reports, and quality indicators while ensuring timely escalation and resolution of identified issues.\nQuality, Compliance & Inspection Readiness\nEnsure all data management activities comply with applicable regulatory requirements, ICH-GCP guidelines, and Oruka Therapeutics SOPs.\nMaintain oversight of all Data Management Trial Master File (TMF/eTMF) documentation.\nParticipate in the review of study documents, including protocols, Safety Monitoring Plans, Statistical Analysis Plans, Communication Plans, and other clinical documentation.\nSupport internal audits, sponsor audits, and regulatory inspections by ensuring inspection readiness and timely resolution of findings.\nMetrics & Continuous Improvement\nDevelop, monitor, analyze, and report data management performance metrics throughout the study lifecycle.\nIdentify and troubleshoot complex data-related issues while implementing proactive solutions to minimize study risk.\nLead Lessons Learned sessions and recommended process improvements to enhance operational efficiency and data quality.\nContribute to the development, review, and continuous improvement of Data Management SOPs, work instructions, templates, and departmental standards consistent with industry best practices and regulatory expectations.\nCommunication & Cross-Functional Collaboration\nLead or participate in Study Kick-Off Meetings, Investigator Meetings, vendor meetings, and cross-functional team meetings.\nPrepare and maintain meeting minutes, action items, and decision logs for Data Management meetings.\nBuild effective working relationships across Clinical Operations, Medical, Safety, Regulatory Affairs, Quality Assurance, Biostatistics, Statistical Programming, and external partners.\nQualifications\nRequired\nBachelor's degree in Life Sciences, Computer Science, Information Technology, or a related scientific discipline.\nMinimum of 10 years of clinical research experience, including at least 5 years of direct Clinical Data Management experience within a Sponsor, CRO, or biotechnology/pharmaceutical environment.\nExperience leading Data Management activities across Phase I-IV clinical trials.\nDemonstrated experience managing CROs and external vendors.\nStrong experience with Electronic Data Capture (EDC) systems such as Medidata Rave, Oracle Clinical, Medrio, Veeva CDMS, or comparable platforms.\nExperience with electronic Trial Master Files (eTMF).\nStrong understanding of GCP, ICH Guidelines, FDA, EMA, PMDA, and other applicable global regulatory requirements.\nExperience reviewing clinical databases, edit checks, CRFs, Data Management Plans, and database validation documentation.\nExcellent organizational, analytical, project management, and problem-solving skills.\nStrong written and verbal communication skills with the ability to collaborate effectively across multidisciplinary teams.\nAbility to independently manage multiple clinical studies and competing priorities in a fast-paced environment.\nPreferred\nWorking knowledge of CDISC standards, including CDASH and SDTM.\nFamiliarity with Pinnacle 21.\nExperience with eCOA/ePRO and IRT/IVRS systems.\nExperience supporting regulatory inspections and sponsor/vendor audits.\nPrevious experience mentoring or leading Clinical Data Managers is preferred.\nCompensation:\nAn appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.\nThe anticipated salary range for candidates is $146,000 to $161,000. 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.\nWe'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.\nSalary Range for the Role\n$146,000—$161,000 USD\nWhat We Offer:\nA chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.\nCompetitive salary and benefits package.\nA supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.\nOpportunities for professional growth and development.","description_format":"text","description_chars":9071,"description_truncated":false,"requirements":{"experience_years_min":10,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Equity"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["CRO & CDMO Services","Biologics & Biosimilars","Immunology & Inflammation Therapeutics"],"lifecycle":[{"event":"open","at":"2026-10-06T23:09:13Z"}],"visa":[],"liveness":{"score":84,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.843,"p_room":1,"age_days":22,"expected_fill_days":65,"reasons":["conf:3","win:early"],"computed_at":"2026-10-29T05:49:05Z"},"pay":{"stated_usd_annual":161000,"is_top_pay":true},"html_url":"https://alion.io/job/oruka-manager-clinical-data-management","json_url":"https://alion.io/job/oruka-manager-clinical-data-management.json","meta":{"generated_at":"2026-10-29T16:17:20Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":24307,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-30T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":688198},"rest":"https://alion.io/mcp/rest/get_company?id=688198"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Foruka-manager-clinical-data-management"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Foruka-manager-clinical-data-management"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Foruka-manager-clinical-data-management"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/oruka-manager-clinical-data-management\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Foruka-manager-clinical-data-management"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":1980232}},{"tool":"search_jobs","arguments":{"company":"oruka.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":1980232},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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