Lead and oversee clinical data management activities across assigned studies, ensuring high-quality data in compliance with ICH-GCP and company SOPs.
Manage CROs and external vendors, including database start-up, data cleaning, and database lock, while maintaining quality, timelines, and budget.
Collaborate cross-functionally with Biometrics, Clinical Operations, Medical, and other teams to drive data management milestones and inspection readiness.
We are developing novel biologics designed to set a new standard for the treatment of chronic skin diseases like plaque psoriasis. As a Nasdaq-listed startup, we foster a vibrant, inclusive culture where everyone is encouraged to bring their authentic selves to work.
Lead clinical data management strategy and execution across the portfolio to ensure data integrity and regulatory submission readiness.
Own end-to-end database lock planning and execution for pivotal trials, ensuring on-time, audit-ready locks.
Build and lead a fit-for-purpose data management team, including internal staff and outsourced functions, and establish SOPs and governance.
Prilenia is a private biopharmaceutical company focused on bringing transformative medicines to people with neurodegenerative diseases such as ALS and Huntington’s disease. They are a small to mid-size clinical-stage organization with a highly committed global team and a flexible, mostly remote culture.
Lead the statistical design and analytical planning for oncology clinical utility studies with innovative methodologies.
Author and review high-quality statistical deliverables including SAPs and reports for cross-functional collaborators.
Mentor early career statisticians and support continuous improvement of departmental processes and tools.
Natera is a global leader in cell-free DNA testing, dedicated to oncology, women's health, and organ health. The team consists of highly dedicated professionals from world-class institutions, working in a fast-paced environment.