Monday, December 12, 2011

Onyx Falls After FDA Refuses Priority Review - Dec. 12, 2011

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Pharm Country (Bridgewater, New Jersey)

Sanofi
Senior Clinical Trial Manager
Responsible for the overall operational planning and activities for the implementation and conduct of clinical exploratory pharmacology clinical trials in compliance with ICH, GCP's, SOPs, local requirements, internal/departmental guidelines, and established timelines.

Biotech Bay (Sunnyvale, California)

Pharmacyclics, Inc.
Clinical Trial Assistant
Ensure studies are completed, on time, within budget and in compliance with SOPs, FDA regulations and ICH/GCP guidelines. Set up CTMS system, as appropriate. Assist in preparation of documents including regulatory document templates, study binders, study communications and presentations.

Genetown (Cambridge, Massachusetts)

Millennium: The Takeda Oncology Company
Global Medical Affairs (GMA) Clinical Research Manager I
Lead provides oversight and management of Investigator Initiated Studies (IIS) for one or more molecule (s), either in development or post approval, within the IIS Program. The IIS Program includes studies submitted from US academic institutions, NCI CTEP/COOP, and Ex-US Investigators and/or COOPs.

Biotech Beach (San Diego, California)

Ardea Biosciences, Inc.
Clinical Trials Assistant
Will support the efforts of a Phase 1, 2 or 3 clinical operations team (special emphasis on Phase 1's). Responsibilities include, but are not limited to maintaining clinical master files, making investigator payments.

BioCapital (Bethesda, Maryland)

Technical Resources International
Attorney/Clinical Trials Agreement Advisor
Will draft and negotiate Clinical Trial Agreements and other research agreements between the government client (National Institutes of Health) and industry collaborators (biologic and drug product manufacturers) and provide counsel on FDA laws and regulations, contracts, intellectual property, access to data, ownership of data and specimens, safety reporting, patient privacy, liability, indemnification, confidentiality, and human subject protection.

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Events

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