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Clinical Project Manager II

Company: Intelliswift Software, Inc
Location: San Mateo
Posted on: November 22, 2021

Job Description:

Title: Clinical Project Manager II Location: Foster City, CA Specific responsibilities

  • May support building Pop PK dataset and process flow, document drafting, ClinPharm timeline in NDA/BLA
  • Leads coordination of document drafting with Medical Writing, Regulatory Project Management and the ClinPharm team and multiple stakeholders and contributors
  • Manages timelines based on submission plans and internal review process
  • Manages deliverables supporting submissions including Pop PK Exposure Data, Pop PK Report, Summary modules, Part 11 Files used to derive Pop PK data, etc. Education and Experience
    • 5+ years relevant experience with BA/BS
    • 3+ years relevant experience with MA/MS/MBA
    • 0+ Years relevant experience with PhD, PharmD , or equivalent
    • Where applicable, multiple years' project management experience in life sciences, including multiple years' experience co-managing project teams.
    • Where applicable, proven effectiveness managing project teams in life sciences.
    • Has complete knowledge of full cycle project management, from project start-up to close-out.
    • Has advanced knowledge of project management best practices and tools and has shown ability to apply these to improve project efficiencies and effectiveness.
    • Has significant industry knowledge, including knowledge of drug development, and is able to flex own knowledge to work on molecule and/or non-molecule projects.
    • Independently solves problems incurred and seeks advice when needed. Ensures solutions are consistent with organizational objectives.
    • Coaches less experienced team members in resolving problems. Job Requirements:Skills: ClinPharm, Clinical Data,--Pop PK, Part 11 Files

Keywords: Intelliswift Software, Inc, San Mateo , Clinical Project Manager II, Healthcare , San Mateo, California

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