Clinical Research-Manager #job

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Matthew Masterson
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Clinical Research-Manager #job

Description:
Lead and manage the execution of a phase IIIb/IV program. Support Global Brand Medical Affairs Lead in planning and conducting clinical trials. Ensure execution of a clinical study program (several Phase IIIB/IV studies supporting marketed products in a given Franchise) within timeline and budget. In particular: Write full or sections of protocol based on approved synopsis; Develop supporting documents, e.g., manual of operations, IB, in a high quality and timely way; Ensure Health Authority and IRB submission and approval.; Work with Alcon Clinical Infometrics or CRO on site selection; Interact with Drug/Device supply management group to ensure test product supply. Track study progress and resolve issues. Interact with keys investigators to identify study issues and actively contribute to resolve them. Ensure ongoing data quality review (masked review). Ensure data cleaning and database lock. Ensure reporting of results to Management and Brand Medical Team. Member of the Brand Medical Team. Coach junior clinical manager.

Requirements:
Master?s in life science is preferred. English 5+ years of experience in Drug/Device Development, especially in managing global multiple site clinical studies; Experience in writing clinical protocols; Several years of experience in running clinical studies independently without significant supervision.

Apply online:
http://www.hirelifescience.com/seeker_jobs.aspx?jobsID=434390&jobtitle=Clinical Research-Manager