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Manager, Clinical Research

Manager, Clinical Research
Jersey City, NJ
DESCRIPTION



  • 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





QUALIFICATIONS


  • 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



Company Description:

About Ascent:


Ascent is a leading national technology consulting and professional services firm that focuses on tactical and strategic consulting. Ascent's fundamental business is providing staffing services to Large Enterprise clients in our core market verticals: Financial Services, Healthcare, and Life Sciences. We focus the majority of our efforts in Staff Augmentation support of Large Enterprise Clients who utilize a Vendor Management System. Ascent works as both a reliable supplier in support of programs, as well as a Strategic Advisor in support of enterprise efforts to establish best in class preferred vendor programs. Ascent was ranked in the 2007 and 2008 Inc. 500 and recognized specifically for its innovative work in staff augmentation support of Large Enterprise preferred vendor accounts.


If you are ready to propel your career to new heights†read on. We are looking for talented and dedicated colleagues to join our phenomenal team. At Ascent, we have created an environment where culture, commitment and opportunity converge to yield a truly unique place to work. We know that every employee has something important to say and that every employee is integral to our success. Where else can you walk over to a founder and talk about your ideas to help build our business and have that idea implemented in 48 hours? More importantly, we do everything we can to make sure our employees not only have great jobs, but great lives.




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