Job Title: Manager of Clinical Data Management
Location: Remote OR Hybrid 3 days/week if located near office in either Waltham, MA or Menlo Park, CA will be required.
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 Management Trial Master File (TMF/eTMF) documentation.
- Participate in the review of study documents, including protocols, Safety Monitoring Plans, Statistical Analysis Plans, Communication Plans, and other clinical documentation.
- Support internal audits, sponsor audits, and regulatory inspections by ensuring inspection readiness and timely resolution of findings.
Metrics & Continuous Improvement- Develop, monitor, analyze, and report data management performance metrics throughout the study lifecycle.
- Identify and troubleshoot complex data-related issues while implementing proactive solutions to minimize study risk.
- Lead Lessons Learned sessions and recommended process improvements to enhance operational efficiency and data quality.
- Contribute 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.
Communication & Cross-Functional Collaboration- Lead or participate in Study Kick-Off Meetings, Investigator Meetings, vendor meetings, and cross-functional team meetings.
- Prepare and maintain meeting minutes, action items, and decision logs for Data Management meetings.
- Build effective working relationships across Clinical Operations, Medical, Safety, Regulatory Affairs, Quality Assurance, Biostatistics, Statistical Programming, and external partners.
QualificationsRequired- 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.
Compensation:- 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.
- The 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.
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.
Salary Range for the Role
$146,000-$161,000 USD
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.
