Manager, Clinical Data Management

oruka; United States; Hybrid; USD 120,000 - 180,000; Full time

Job summary

Oruka Therapeutics, a Nasdaq-listed biotech, seeks an experienced Manager, Clinical Data Management to lead data management across Phase I–IV studies. You will ensure timely delivery of high-quality data in compliance with ICH‑GCP and SOPs, and act as the primary DM lead for assigned trials.

In a remote or hybrid role (office in Waltham, MA when onsite), you will oversee CROs, study start-up, database development, data cleaning, and final database lock, collaborating with Biometrics, Statistics,

Responsibilities

• 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.
• 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.
• 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.
• 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.
• Ensure all data management activities comply with applicable regulatory requirements, ICH‑GCP guidelines, and Oruka Therapeutics SOPs.

Job description

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.
• Maintain oversight of all Data Manageme