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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
QA Associate, Complaints 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
Scientist California
9/19/2016 8:16 AM

Initiates, directs and executes scientific studies for multiple projects for the INTERCEPT Blood System. Focus on internal studies used for product development and registration efforts. Primary Responsibilities: • Act independently as Study Director: Experimental design, preparation of protocol, study execution, data analysis, and preparation of final report • Perform platelet and coagul  ...View Job
Sr. Regulatory Affairs Specialist California-Oakland/East Bay
9/2/2016 10:41 AM

Coordinate and prepare documents for submissions to regulatory agencies worldwide, as appropriate by project. Primary Responsibilities: • Coordinates and prepares (i.e., plans, writes, and reviews) timely submissions, including interfacing with other departments to obtain the necessary components and reports in accordance with regulatory agencies’ guidelines for approval by Manager. • Revi  ...View Job
Clinical Trial Manager California-Oakland/East Bay
9/1/2016 3:56 PM

Direct and coordinate the operational and logistical activities of all assigned clinical operations projects. Primary Responsibilities: • Responsible for managing activities associated with the conduct of assigned clinical trials. • Evaluate, monitor and facilitate the flow of clinical data to ensure accuracy. • Develop protocols, consent forms, monitoring plans, case report forms and othe  ...View Job
Mass Spectrometry Scientist California
9/1/2016 3:20 PM

Support projects focused on mass spectrometry extraction; generating and analysis of mass spec (MS) data. Primary Responsibilities: • Develop and validate quantitative mass spectrometry analysis of compounds from biological matrices. • Independent ability to operate and troubleshoot mass spectrometer and/or LC. • Independent ability to design, execute, and analyze mass spec data from exp  ...View Job
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