Open Positions In Fremont

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Clinical Data Analyst

July 17th, 2018|

 

Summary/Objective

Works collaboratively with clinical project team staff to meet project deliverables and timelines for clinical data acquisition, quality checking and reporting. Ensures completeness, correctness and consistency of clinical data and data structure. Responsibilities include: Implement the data management portions of clinical research projects. Review study protocols and assist site coordinators, investigators, and field clinical […]

Clinical Trial Manager

July 10th, 2018|

Reports to:  Director, Clinical Operations

Summary/Objective

The primary responsibility of the Clinical Trial Manager II is to manage the day-to-day Clinical Operation activities associated with the execution of clinical studies. This position provides leadership and functional oversight to the various study teams, serves as the primary contact regarding all program activities and may act to advise […]

Sr Regulatory Affairs Specialist

June 24th, 2018|

Reports to

Executive Vice President, Regulatory Affairs

Summary/Objective

This position is responsible for supporting all regulatory projects in conjunction with other regulatory and clinical professionals

Essential Functions

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Prepare regulatory submissions, e.g., FDA IND supplements and international clinical trial applications (CTA).
Coordinate submission components, perform final preparation, assembly, […]