Senior Clinical Data Management Lead

Oruka Therapeutics Inc; Boston (MA); Hybrid; USD 146,000 - 161,000; Full time

Benefits offered by this job

Startup culture

Competitive salary

Benefits package

Growth opportunities

Job summary

Oruka Therapeutics Inc is seeking a Manager of Clinical Data Management to oversee data management across multiple early- to late-phase studies, ensuring high-quality data in compliance with ICH-GCP.

The role requires leading CDM activities, managing CROs, and coordinating with cross-functional teams, with a focus on eTMF and EDC systems. This position reports to the Senior Director, Data Management and offers a competitive compensation and collaborative culture.

Qualifications

• Bachelor's degree in Life Sciences or related field.
• Minimum of 10 years of clinical research experience, including at least 5 years in Clinical Data Management.
• Experience leading Data Management activities across Phase I–IV trials.
• Experience managing CROs and external vendors.
• Strong experience with EDC systems (Medidata Rave, Oracle Clinical, Medrio, Veeva CDMS).
• Solid understanding of GCP/ICH guidelines and regulatory requirements.
• Excellent organizational and communication skills.

Responsibilities

• Lead or oversee all CDM activities across assigned trials.
• Coordinate CROs and external vendors to meet timelines and budgets.
• Develop study timelines and data management deliverables.
• Ensure inspection readiness and regulatory compliance.
• Collaborate with cross-functional teams including Biostatistics and Programming.

Skills

Clinical data management

CRO management

EDC systems

GCP & ICH

Team leadership

Regulatory knowledge

Education

Bachelor's degree in Life Sciences or related

Tools

Medidata Rave

Oracle Clinical

Medrio

Veeva CDMS

eTMF systems

Job description

Oruka Therapeutics Inc is seeking a Manager of Clinical Data Management to oversee data management across multiple early- to late-phase studies, ensuring high-quality data in compliance with ICH-GCP.

The role requires leading CDM activities, managing CROs, and coordinating with cross-functional teams, with a focus on eTMF and EDC systems. This position reports to the Senior Director, Data Management and offers a competitive compensation and collaborative culture.