Remote Lead, Clinical Data Management

Remote; San Francisco (CA); Hybrid; USD 146,000 - 161,000; Full time

Job summary

Oruka Therapeutics is seeking a Manager of Clinical Data Management to lead and oversee data management across multiple clinical studies. This remote/hybrid role partners with CROs and internal teams to ensure high-quality data in compliance with ICH-GCP and SOPs, from study start-up through database lock and submission.

The ideal candidate has a minimum of 10 years in clinical research, with 5+ years in CDM and experience managing CROs, EDC systems, and eTMF.

Qualifications

• Bachelor's degree in Life Sciences, Computer Science, IT, or related field.
• Minimum 10 years of clinical research experience with at least 5 years in direct Clinical Data Management.
• Experience leading Data Management across Phase I–IV trials.
• Strong experience managing CROs and external vendors.
• Experience with EDC systems (Medidata Rave, Oracle Clinical, Medrio, Veeva CDMS).
• Experience with eTMF and regulatory submissions.
• Solid knowledge of GCP/ICH guidelines and global regulations.

Responsibilities

• Lead CDM for Phase I–IV trials.
• Oversee CRO data management from start-up to database lock and CSR.
• Primary Data Management contact for CROs and vendors.
• Develop and manage study timelines with internal teams and CRO partners.
• Ensure data quality for interim analyses, database lock, and regulatory submissions.
• Maintain TMF/eTMF documentation and inspection readiness.
• Monitor data management metrics and drive process improvements.
• Oversee vendor budgets, SOWs, and change orders.

Skills

Leadership

Project management

Communication

Problem solving

Cross-functional collaboration

Attention to detail

Education

Bachelor's degree

Tools

Medidata Rave

Oracle Clinical

Medrio

Veeva CDMS

eTMF

eCOA/ePRO

CDISC (CDASH/SDTM)

Job description

Oruka Therapeutics is seeking a Manager of Clinical Data Management to lead and oversee data management across multiple clinical studies. This remote/hybrid role partners with CROs and internal teams to ensure high-quality data in compliance with ICH-GCP and SOPs, from study start-up through database lock and submission.

The ideal candidate has a minimum of 10 years in clinical research, with 5+ years in CDM and experience managing CROs, EDC systems, and eTMF.