Senior Manager / Manager, Clinical Data Management

We are seeking a dedicated and detail-oriented person to support data management activities for clinical trials at Kodiak Sciences in Palo Alto, CA. The ideal candidate will bring strong hands-on experience and a collaborative mindset to contribute to database development, data quality oversight, and vendor coordination.

Requirements

• Support the design, development, and validation of clinical trial databases and electronic Case Report Forms (eCRFs) at the study level.
• Oversee data cleaning, query resolution, and delivery of high-quality datasets to support trial milestones and regulatory submissions.
• Collaborate with external data management vendors to ensure timely and high-quality deliverables; track performance against project timelines and quality standards.
• Participate in the preparation, review, and validation of submission-ready datasets for regulatory filings (e.g., NDA, BLA, MAA).
• Ensure compliance with industry standards and regulations (GCP, FDA, EMA) and assist in audit and inspection readiness.
• Coordinate with internal stakeholders including Clinical Operations, Biostatistics, Regulatory Affairs, and IT to ensure smooth data integration and reporting.
• Contribute to the implementation and optimization of clinical data systems and tools (e.g., EDC, data review platforms).

Benefits

• Competitive salary
• Comprehensive benefits package
• Opportunities for professional growth and development