Program Manager, Clinical Development
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POST DATE 9/15/2016
END DATE 10/24/2016
Jersey City, NJ
JOB DESCRIPTIONGlobal pharmaceutical firm is seeking a Program Manager, Clinical Development to work in Jersey City, NJ.
This is a 6-month contract assignment, with the possibility of extension/temp-to-hire.
Max pay is $86/hour, depending on experience, education and salary history.
Reports to the Director, Clinical Program Management, Clinical Development and supports various activities within Clinical Development, including:
Protocol, ICF, and CSR content development
Clinical data review and protocol devation review/evaluation
Authoring Clinical sections of regulatory documents (IND annual reports/DSUR/PSUR, etc.)
Manage clinical program timelines and budgets for assigned products
Author or provide Clinical input and review of study-related documents (vendor spec documents, patient facing materials, site instructions, training materials, recruitment materials, user acceptance testing, etc.)
Support Clinical pre-approval inspection activities
Advanced degree (Master?s, PharmD, PhD), preferably in life sciences/health-related field or commensurate work experience.
Minimum of 5 to 7+ years of pharmaceuticals/biotech experience
5+ years drug development experience in the pharmaceutical industry, biotech, CRO or commensurate clinical/medical research experience with emphasis on Phase II-IV clinical trials
Thorough understanding of core principles of clinical development (ph2-4), ICH/GCP, and operational & scientific aspects of trial conduct
Thorough understanding of principles of clinical trial data analysis, interpretation and oversight.
Ability to work across programs.
Strong project management, leadership and mediation skills within a matrix environment.
Strategic thinking, ability to work across broad range of interfaces, and identify issues and expedite solutions and resolve conflicts.
Excellent verbal and written communication skills
Exemplary interpersonal and influence skills
Experience in pediatric studies is a plus We are an equal employment opportunity employer and will consider all qualified candidates without regard to disability or protected veteran status.