Statistical Programmer California
9/30/2016 5:44 PM

Responsible for providing clinical data management programming support, Primary Responsibilities: • Assist Data Management and Biostatistics by developing tools and techniques to improve process efficiency, including but not limited to development of edit check programs to improve the data quality and consistency and development of tools to track receipt vs. entry of Case Report Forms (CR  ...View Job
Product Complaint Associate California-Oakland/East Bay
9/29/2016 6:17 PM

Primarily responsible for managing product complaints in compliance with regulatory requirements (FDA, MDD) and ISO standards. Will also provide regulatory compliance support as necessary. Primary Responsibilities: • Register Technical Product Complaints (TPCs) • Opening TPCs for all SAEs, AEs, other events coming into the AER Argus system workflow • Monitoring complaints for timely foll  ...View Job
Scientist, Hematology California-Oakland/East Bay
9/29/2016 2:29 PM

Initiates, directs and executes scientific studies for multiple projects for the INTERCEPT Blood System. Focus on registration studies with external collaborators. Primary Responsibilities: • Act independently as Study Director: Experimental design, preparation of protocol, study execution, data analysis, and preparation of final report • Assist in planning and conduct of external regist  ...View Job
QA Associate California
9/29/2016 12:40 PM

Primarily responsible for assuring compliance with regulatory requirements (FDA, MDD) and ISO standards. Will provide GMP, and ISO 13485 compliance support as necessary. Primary Responsibilities: • Review manufacturing, QC, release records, and documentation for medical device and drug substance/drug product. • Audit reports and raw data for compliance with protocols, SOPs and regulations  ...View Job
Corporate Counsel California-Oakland/East Bay
9/27/2016 11:21 AM

Provide corporate legal services in support of the Company’s research and development and clinical activities, with overflow support for corporate, commercial and sales activities. Primary Responsibilities: • Prepare, review, revise and/or negotiate contracts, including clinical trial agreements, informed consent forms, material transfer agreements, sponsored research agreements, research an  ...View Job
Clinical Data Manager California
9/27/2016 10:28 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