Lead Clinical Data Manager – Remote

Oruka Therapeutics Inc; United States; Hybrid; USD 146,000 - 161,000; Full time

Benefits offered by this job

Competitive salary

Equity/bonus opportunity

Professional growth

Inclusive team environment

Job summary

Oruka Therapeutics is seeking a highly experienced Manager of Clinical Data Management to lead data activities across multiple studies and ensure high-quality data in line with ICH-GCP. You will collaborate with CROs, vendors, and cross-functional teams to drive timelines, budgets, and data integrity from start-up to database lock.

The role reports to the Senior Director, Data Management and requires deep knowledge of EDC systems, data validation, and TMF/eTMF oversight, with strong leadership

Qualifications

• Bachelor's degree in Life Sciences, Computer Science, Information Technology, or related field.
• Minimum of 10 years of clinical research experience, including at least 5 years in Clinical Data Management.
• Experience leading Data Management across Phase I–IV trials.
• Strong experience managing CROs and external vendors.
• Excellent organizational, analytical, and communication skills.

Responsibilities

• Lead Clinical Data Management for Phase I–IV trials.
• Oversee CRO data management activities from start-up to database lock.
• Collaborate with cross-functional teams and vendors.
• Develop study timelines and ensure milestones are met.
• Maintain TMF/eTMF documentation and inspection readiness.

Skills

Clinical Data Management

Project management

Leadership

Communication skills

Education

Bachelor's degree in Life Sciences, Computer Science, Information Technology, or related

Tools

Medidata Rave

Oracle Clinical

Medrio

Veeva CDMS

eTMF systems

Job description

Oruka Therapeutics is seeking a highly experienced Manager of Clinical Data Management to lead data activities across multiple studies and ensure high-quality data in line with ICH-GCP. You will collaborate with CROs, vendors, and cross-functional teams to drive timelines, budgets, and data integrity from start-up to database lock.

The role reports to the Senior Director, Data Management and requires deep knowledge of EDC systems, data validation, and TMF/eTMF oversight, with strong leadership