The Clinical Research Associate monitors activities of a clinical study and at clinical study site to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols. - Review regulatory documents as required and prepare site visit...

Lexicon is a biopharmaceutical company focused on discovering and developing breakthrough treatments for human disease located in The Woodlands, Texas and Princeton, New Jersey. We currently have multiple programs in clinical development for...

Responsible for implementing set-up, execution, oversight and reporting of clinical studies while ensuring that the conduct of the trial is in compliance with the protocol, ICH/GCP, and applicable regulatory requirements. Key...

StemCells, Inc. is engaged in the research, development, and commercialization of cell-based therapeutics and tools for use in stem cell-based research and drug discovery. The Company’s lead therapeutic product candidate, HuCNS-SC® cells (purified...

Manager, Biostatistics is responsible for leading the planning, statistical analysis and reporting for assigned clinical and/or non-clinical projects using both internal and external resources. This position has no direct reports. ESSENTIAL...

Direct all aspects of the company's Global Clinical Compliance Assurance Function so as to provide Compliance and Quality oversight of GCP and Clinical Trial Management. The Director will provide scientific and practical leadership to compliance...

This individual will be the representative for assigned project(s) (i.e., INDs, IND amendments, annual reports, FDA meeting packages, NDAs, NDA amendments, etc.) He/she will functions as a Project Manager, working with other departmental and...