Sr. Manager, Data Management

Sr. Manager, Data Management

Clinical Development, Clinical Operations & Medical Affairs Palo Alto, California

Description

Kodiak Sciences is a fast-growing clinical-stage biotechnology company with a strong focus in ophthalmology. Our Antibody Biopolymer Conjugate Drug (ABCD) platform merges the fields of protein engineering, organic chemistry, and polymer chemistry and is at the core of our discovery engine.We are seeking a skilled and experiencedSenior Manager, Data Management, to lead and oversee critical data management activities supporting clinical trials and regulatory submissions. The ideal candidate will bring expertise in clinical trial database development, vendor management, and data quality oversight. This role will also provide hands-on support and collaborate closely with cross-functional teams to ensure high-quality and compliant data management processes. Key Responsibilities

• Contribute to data management activities to support regulatory submissions, including preparation and validation of submission-ready datasets. Contribute to the creation and review of Data Management sections in regulatory filings such as NDA / BLA / MAA submissions.
• Oversee the design, development, and validation of clinical trial databases and eCRFs at the study level. Ensure timely and accurate data capture, cleaning, and reporting for all clinical studies from vendors. Serve as the primary Data Management point of contact for clinical study teams and external vendors.Provide hands-on support for database development, data validation, data query resolution, and review of submission-ready datasets when needed.
• Manage relationships with external data management vendors, ensuring adherence to contracts, timelines, and quality standards. Contribute to the selection, implementation, and maintenance of data management tools (e.g., EDC systems and data review platforms).
• Ensure compliance with GCP, FDA, EMA, and other applicable regulatory standards. Collaborate with Quality Assurance and Regulatory teams to support audits and inspections.
• Partner with Clinical Operations, Biostatistics, Regulatory Affairs, and IT teams to ensure seamless data flow and analysis. Collaborate on data governance initiatives and integrate processes for effective data lifecycle management.
• Manage, mentor and guide junior data managers.

Qualifications

Apply Apply Later Back to current listings

Share

lang : en_US LinkedIn Email