Clinical Study Planning Mgr

Thousand Oaks, California | Contract

Post Date: 04/20/2015 Job ID: 602

JOB DESCRIPTION:

The  Clinical Study Planning Manager (CSP) is a Role within the development operations organization, and assists the Clinical Research Manager (CRM) and development functions in tracking, documenting, and ensuring quality and timely delivery of all clinical trial deliverables. The CSP is accountable for co-developing and monitoring the implementation of high-quality, realistic, cross-functional, clinical study timelines for company drug development programs from study concept through completed clinical study report. This role ensures alignment with the Integrated Project Plan timelines managed by R&D Project Management, and works with the Clinical Research Manager and CST to monitor progress against the plan and against established process metrics.


 

Responsibilities:

  • Co-developing and validating study-specific timelines
  • Accurately maintaining clinical study timeline information in company data control systems (e.g., APECS)
  • Assisting in all aspects of initiating, planning, executing, controlling, and risk management of all clinical trial activities
  • Facilitating communication of information on clinical trial status, changes, and issues to team members and stakeholders (e.g., dept. heads)
  • Contributing to the development of high performing CSTs and functional teams
  • Leading special projects as assigned
  • Rapidly identifying variances within clinical study timelines that require corrective action
  • Adhering to all Amgen policies, clinical development processes, SOPs, and clinical project management processes


Basic Qualifications:

Doctorate degree
OR
Master’s degree & 3 years of clinical experience
OR
Bachelor’s degree & 5 years of clinical experience
OR
Associate’s degree & 10 years of clinical experience
OR
High school diploma / GED & 12 years of clinical experience

Preferred Qualifications:

  • MS or advanced degree preferred.
  • Knowledge of project management tools and processes (e.g. MS Project) and strong computer literacy, including word processing, presentation, and spreadsheet applications.
  • Experience in working with teams in a matrix environment.
  • Familiarity with project management principles and practices.
  • Project Management Professional (PMP) certification.
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