Associate Director, Product Safety California-Oakland/East Bay
5/13/2016 10:44 AM

Ensur compliance with regulations for the collection and reporting of adverse events to regulatory agencies. Review and interpret clinical data, write, edit, compile and QC documents, ensuring accuracy and quality of written deliverables with regulatory standards. Primary Responsibilities: Product Safety: • Develop and maintain Drug Safety database. • Provide user training and safety tr  ...View Job
Clinical Data Manager California
5/13/2016 10:41 AM

As a Clinical Data Manager (CDM), the candidate will be responsible for providing quality management of clinical trial data in a rapidly-evolving environment. The CDM will lead the data management activities including Case Report Form (CRF) designing, database designing, developing Data Management Plan, CRF annotation, implementing edit check programs, data entry and query status tracking, and da  ...View Job
CMC Stability, Analytical & Validation Manager California
5/3/2016 5:23 PM

Responsible for all phases of the product stability testing program to include devices, components, drug substance, and drug product. Manage new and ongoing studies necessary to ensure complete and accurate data is available for establishing storage requirements and expiration dating periods for all products and in-process materials. Convert raw data into stability reports to support regulatory f  ...View Job