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Oruka Therapeutics is a biopharmaceutical company developing biologic medicines for chronic skin diseases, with a focus on plaque psoriasis and related inflammatory conditions. Its team of experienced biopharma professionals is advancing monoclonal antibody therapies intended to support more complete disease clearance while reducing dosing frequency. The company’s work centers on improving treatment outcomes and patient experience in dermatology and inflammatory disease care.
Clinical Data Management Manager - Oruka Therapeutics (Hybrid)
Lead clinical data management for Phase I-IV studies at Oruka Therapeutics, a biotechnology company developing biologics for chronic skin diseases. Oversee CROs, clinical databases, data quality, vendor reconciliation, and regulatory readiness.
United States
Massachusetts$146,000 – $161,000 / year
HybridFull-timeSeniorLeadEnglish RequiredClinical ResearchDescription
- Direct clinical data management activities for assigned Phase I-IV clinical studies
- Act as lead Clinical Data Manager for approximately three to four studies from start-up through conduct, database lock, and closeout
- Manage CRO and vendor activities, schedules, deliverables, budgets, and contractual commitments
- Oversee the design, development, testing, and validation of clinical databases, eCRFs, edit checks, data validation specifications, and UAT
- Review and approve Data Management Plans, CRFs, completion and review guidelines, edit check specifications, and related documents
- Direct data cleaning and reconciliation for laboratory, ECG, imaging, eCOA/ePRO, and other vendor data
- Safeguard data quality during interim analyses, database freezes, unlocks, and final database lock
- Maintain data review logs and coordinate resolution of queries and data issues with CROs
- Collaborate with Biometrics, Statistical Programming, and Biostatistics on listings, reports, patient profiles, and programming checks
- Ensure adherence to regulatory requirements, ICH-GCP guidelines, and company SOPs
- Maintain Data Management TMF/eTMF records and support audits and regulatory inspections
- Develop and report data management performance metrics while driving process improvements
- Lead or contribute to study kick-off, investigator, vendor, and cross-functional meetings
- Build effective partnerships with Clinical Operations, Medical, Safety, Regulatory Affairs, Quality Assurance, Biostatistics, Statistical Programming, and external partners
- Report to the Senior Director of Data Management
Requirements
- Bachelor's degree in Life Sciences, Computer Science, Information Technology, or a related scientific discipline
- At least 10 years of clinical research experience, including 5 or more years in direct Clinical Data Management within a sponsor, CRO, biotechnology, or pharmaceutical organization
- Track record of leading Data Management activities across Phase I-IV clinical trials
- Experience overseeing CROs and external vendors
- Proficiency with Electronic Data Capture systems such as Medidata Rave, Oracle Clinical, Medrio, Veeva CDMS, or comparable platforms
- Experience working with electronic Trial Master Files (eTMF)
- Thorough knowledge of GCP, ICH Guidelines, FDA, EMA, PMDA, and other applicable global regulatory requirements
- Experience reviewing clinical databases, edit checks, CRFs, Data Management Plans, and database validation documentation
- Strong organizational, analytical, project management, and problem-solving capabilities
- Clear written and verbal communication skills, with the ability to work effectively across multidisciplinary teams
- Ability to manage multiple clinical studies and competing priorities independently in a fast-paced setting
Benefits
- Competitive salary and benefits package
- Equity participation
- Opportunity for a performance-related bonus
- Supportive and inclusive team environment
- Professional growth and development opportunities
- Energetic startup culture
- Chance to contribute directly to bringing new medicines to patients
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