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Project Manager-Pharma

Company: Ambry Genetics
Location: Aliso Viejo
Posted on: June 24, 2022

Job Description:

JOB TITLE: Project Manager-Pharma DEPARTMENT: PMOREPORTS TO TITLE: Program Manager JOB OVERVIEW I. Job Overview : The Project Manager is responsible for leading custom collaboration projects brought to Ambry through business development, clinical collaborations, or other custom business opportunities. The project manager will lead the achievement of project objectives and completion on time, on budget, and in conformance to Ambry Genetics' project management methodologies and standards. The Project Manager works independently under general direction assuming primary responsibility for planning, directing, coordinating and delivering project activities through the entire project life cycle. The Project Manager will be part of the Project Management Organization (PMO) at Ambry Genetics. II. Duties and Responsibilities:

  • Lead project teams of moderate and complex projects.
  • Prepares project plans, financial analysis, schedules and budgets by using project management tools and by working with appropriate staff to understand tasks necessary to complete a project.
  • Communicates project status by preparing standard status reports / meeting minutes, and by participating in PMO and customer project status update meetings.
  • Resolves project issues by working with internal and external team members, project customers, and others as appropriate.
  • Influences middle management on technical or business solutions
  • Complete all project-specific activities such as, but limited to organization of study protocols, coordination of SIV/SQV, support quality department with audits, sample tracking and management, data transfer as applicable to scope of work, invoicing, etc.
  • Build and maintain external relationships by; meeting coordination, status updates, follow ups, meeting management (i.e., agendas, meeting minutes, etc.)
  • Utilizes project management tools to maintain, track, monitor and record project timelines, tasks, risks, KPIs, communication plans, etc.
  • Maintains ownership of documents within the specified document control management system (i.e., Veeva, Launch, etc.)
  • Support review process of contracts by coordinating meetings and gathering input from affected stakeholders and ensuring final sign off by legal.
  • Attend and participate in department meetings, program specific meetings and others as needed. JOB SPECIFICATIONS IV. EDUCATION and Knowledge: - Bachelor's Degree in Science preferred - Certifications in Project Management (i.e. PMP, CAPM, Lean Six-Sigma) is a plus V. TECHNICAL COMPETENCIES (Skill, Abilities and Capabilities):
  • Excellent customer and service focus
  • Excellent written, verbal, and interpersonal communication skills.
  • Demonstrated success working with a team. Must be able to influence without authority.
  • Demonstrated knowledge of operational/logistical aspects of clinical testing as well as regulatory requirements.
  • Wide application of technical principles, practices, and procedures. Strong understanding of business unit function and cross group dependencies/relationships.
  • Prior experience with contracts or contracting process.VI. EXPERIENCE:
    • 1.5 - 3 years of project management experience
    • 6+ years of related work experience with a strong understanding of clinical diagnostics, or an equivalent combination of education and work experience.
    • Experience with GCP, GLP, GMP is a plus
    • Knowledge of clinical trial life cycle is preferred
    • Prior Document Control, Clinical Trial Management System, etc. is a plus

Keywords: Ambry Genetics, Aliso Viejo , Project Manager-Pharma, Executive , Aliso Viejo, California

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