Kodiak Sciences · 13 hours ago
Manager, Clinical Data Management
Palo Alto, CA
Full-time
Onsite
Senior Level
7+ years expKodiak Sciences is a biopharmaceutical company focused on developing transformative therapeutics for retinal diseases. The Manager, Clinical Data Management will support data management activities for clinical trials, ensuring high-quality and compliant data for regulatory submissions.
BiotechnologyHealth CareTherapeutics
Responsibilities
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)
Qualification
Required
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)
Strong problem-solving, organizational, and communication skills
Preferred
Demonstrated experience supporting regulatory submissions is a plus
Company
Kodiak Sciences
Kodiak is designing and developing novel therapies for the treatment of retinal disease.
51-200 employees
H1B Sponsorship
Kodiak Sciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (4)
2024 (9)
2022 (2)
2021 (3)
Funding
Current Stage
Public CompanyTotal Funding
$1.22B2025-12-16Post Ipo Equity· $184M
2020-11-17Post Ipo Equity· $645M
2019-12-02Post Ipo Equity· $317.4M
Leadership Team
Victor Perlroth
Chairman and CEO
Recent News
2025-12-22
2025-12-18
Company data provided by crunchbase