Program Manager, Clinical Development

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POST DATE 9/15/2016
END DATE 10/24/2016

AppleOne Jersey City, NJ

Company
AppleOne
Job Classification
Full Time
Company Ref #
23177383.30867
AJE Ref #
576183011
Location
Jersey City, NJ
Job Type
Regular
Required Licenses/Certifications
df-aj

JOB DESCRIPTION

APPLY
Global 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.

SUMMARY
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


Requirements:

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.