Program Manager, Clinical Development (440666)
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POST DATE 9/12/2016
END DATE 10/9/2016
Jersey City, NJ
JOB DESCRIPTIONJob Description:
Summary: Reports to the Director, Clinical Program Management, Clinical Development and supports various activities within Clinical Development, including: Conducts clinical data review and protocol deviation review/evaluation Authors Clinical sections of regulatory documents (IND annual reports/DSUR/PSUR, etc.) Manages clinical program timelines and budgets for assigned products Authors or provides clinical input and review of study-related documents (vendor spec documents, patient facing materials, site instructions, training materials, recruitment materials, user acceptance testing, etc.) Supports Clinical pre-approval inspection activities Follows protocol, ICF, and CSR content development Skills needed: 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 Basic Qualifications:Minimum Qualifications: Advanced degree (Masters, 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
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