Manager, Clinical Data Management

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:

Manager of Clinical Data Management

Location:

Remote OR Hybrid in Waltham, MA office, will be required 3 days/week if located near office.

Role Overview:

Oruka 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).

The 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.

This position reports to the Senior Director, Data Management.

Key Responsibilities:

• Clinical Data Management Leadership
• Serve as the lead Clinical Data Manager for assigned Phase I-IV clinical trials.
• Provide strategic oversight of all CRO data management activities from database start-up through database lock, clinical study report (CSR), and regulatory submission.
• Serve as the primary Data Management representative and point of contact for CROs, third-party vendors, and internal cross-functional study teams.
• Develop and manage study timelines in collaboration with internal teams and CRO partners to ensure all data management milestones and deliverables are achieved.
• Database Development & Study Start-Up
• Oversee 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).
• Review and approve key data management documentation, including: Data Management Plans (DMPs)
• Case Report Forms (CRFs)
• CRF Completion Guidelines
• Manual Data Review Guidelines
• Edit Check Specifications
• Data Validation Specifications
• Other study-specific data management documentation
• Participate in the development and review of specifications for related clinical technologies, including eCOA/ePRO and IRT/IVRS systems.
• Data Review & Database Lock
• Oversee all study-related data cleaning activities, including reconciliation of external data sources such as laboratory, ECG, imaging, eCOA/ePRO, and other vendor data.
• Ensure clinical and external data meet quality standards required for interim analyses, database freezes, unlocks, and final database lock.
• Conduct ongoing internal review of study data throughout study conduct to proactively identify and resolve data quality issues.
• Maintain the internal Data Review Log and collaborate with CROs to ensure timely resolution of all outstanding queries and data issues.
• Partner with Biometrics, Statistical Programming, and Biostatistics to develop oversight listings, patient profiles, reports, and programming checks that support efficient data review.
• Vendor Oversight & Financial Management
• Provide oversight of Data Management CROs and external vendors to ensure high-quality deliverables, adherence to timelines, and compliance with contractual obligations.
• Review Statements of Work (SOWs), Requests for Proposals (RFPs), budgets, and Change Orders for completeness, accuracy, and alignment with study objectives.
• Review vendor metrics, reconciliation reports, and quality indicators while ensuring timely escalation and resolution of identified issues.
• Quality, Compliance & Inspection Readiness
• Ensure all data management activities comply with applicable regulatory requirements, ICH-GCP guidelines, and Oruka Therapeutics SOPs.

Qualifications

• Required
• Bachelor's degree in Life Sciences, Computer Science, Information Technology, or a related scientific discipline.
• Minimum 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.
• Experience leading Data Management activities across Phase I-IV clinical trials.
• Demonstrated experience managing CROs and external vendors.
• Strong experience with Electronic Data Capture (EDC) systems such as Medidata Rave, Oracle Clinical, Medrio, Veeva CDMS, or comparable platforms.
• Experience with electronic Trial Master Files (eTMF).
• Strong understanding 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.
• Excellent organizational, analytical, project management, and problem-solving skills.
• Strong written and verbal communication skills with the ability to collaborate effectively across multidisciplinary teams.
• Ability to independently manage multiple clinical studies and competing priorities in a fast-paced environment.
• Preferred
• Working knowledge of CDISC standards, including CDASH and SDTM.
• Familiarity with Pinnacle 21.
• Experience with eCOA/ePRO and IRT/IVRS systems.
• Experience supporting regulatory inspections and sponsor/vendor audits.
• Previous experience mentoring or leading Clinical Data Managers is preferred.

What We Offer:

A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.

Competitive salary and benefits package.

A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.

Opportunities for professional growth and development.