Manager, Clinical Data Management

Overview

Kodiak Sciences is a biopharmaceutical company committed to researching, developing, and commercializing transformative therapeutics to treat a broad spectrum of retinal diseases. We are focused on bringing new science to the design and manufacture of next-generation retinal medicines to prevent and treat the leading causes of blindness globally. This role is on-site at Kodiak's headquarters in Palo Alto, CA.

• 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).

• Bachelor’s degree in Life Sciences, Data Science, Computer Science, or a related field.
• 7+ years of experience in clinical data management within the biotech, pharmaceutical, or CRO industry.
• Experience managing study-level data management activities and working with external vendors.
• Familiarity with clinical data systems (e.g., Medidata RAVE, Oracle Clinical, Veeva) and industry data standards (e.g., CDISC, SDTM).
• Demonstrated experience supporting regulatory submissions is a plus.
• Strong problem-solving, organizational, and communication skills.