DescriptionThis role is on-site at Kodiak's headquarters in Palo Alto, CA.
We are seeking a dedicated and detail-oriented person to support data management activities for clinical trials. This role will contribute to database development, data quality oversight, and vendor coordination to ensure accurate, compliant, and submission-ready data. The ideal candidate will bring strong hands-on experience and a collaborative mindset, working closely with cross-functional teams to drive successful trial execution and regulatory submissions.
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).
Education / Qualifications- Bachelor's degree in Life Sciences, Data Science, Computer Science, or a related field.
- 10+ 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.
