Senior IT Portfolio Manager, R&D Applications (Pharmaceutical)

Location: Sunnyvale, CA
Date Posted: 01-25-2018
Title: Senior IT Portfolio Manager, R&D Applications
Location: San Francisco Bay Area, CA
Duration: Long-Term Contract (1099, C2C, or W-2)

We are seeking a highly skilled Pharmaceutical Program Manager who has experience in managing a large portfolio of R&D Projects. Must have recent pharmaceutical experience and experience managing IT projects and programs with Pharma/BioTech R&D area!

This role will be responsible for managing the project portfolio for the IT group which support applications and systems for Research & Development, including Labs.  Project and systems involve Clinical Trial Management System (CTMS), Enterprise Document Management Systems (EDMS), CQMS, RBM, LIMS applications,  IT R&D Data Warehousing, Veeva VAULT, SharePoint, CRO data integrations, most involving CSV – Computerized System Validation / 21 CFR Part 11. Ability to develop relationships with R&D stakeholders, internally within IT and business executives. This role demands strong, senior PM with excellent track record of managing Programs, adhering to IT PMO process.

Key Accountabilities/Core Job Responsibilities:
  • Oversight and management of R&D Application IT project portfolio, working in support of the IT PMO
  • Pro-actively lead portfolio planning, statusing, risk mitigation activities and coordinate tightly with IT R&D Management, as well as with business SMEs, IT architect, IT business analysts, developers to ensure projects, programs progress from Initiation, Planning, Design-Build, Transition to Production, Closure.
  • Guide IT Management and Business Partners through process for assembling Project proposals and ensuring they obtain appropriate Approvals via steering groups.
  • Coordinate with IT PMO to stage projects for Initiation phase and run the project or hand-off to Project Manager.
  • Author project documentation including Program Charter, Budget Trackers, Portfolio Schedule, Status Dashboard, Timeline visuals – and guide other area Project Managers to follow IT PMO process and formats.
  • Professionally prepare presentations for IT, Business executives to status, roadmap, strategize programs and projects
  • Manage internal relationships with R&D business leadership, drive steering meetings for prioritization, escalation to obtain timely decisions
  • Ensure GxP validated solutions comply with FDA regulations throughout the solution lifecycle, working tightly with internal IT Validation and IT Quality SMEs.
  • Monitor High Risk programs and projects, ensure optimal Risk Management plans exist.
  • Escalate issues to Sr. Management, and to vendor support as needed

Qualifications, Experience and Education Requirements:
  • 10+ years of experience managing IT projects and programs with Pharma/BioTech R&D area
  • Strong interpersonal and communication skills; ability to interact with different levels of management; ability to lead meetings with authority.
  • Seasoned Pharmaceutical R&D business acumen.
  • Project management experience in the Bio-Pharma, Life Sciences industry is mandatory.
  • Skills: Program and Portfolio Management, SDLC, Business Analysis, Vendor Management, Meeting Management, Team Leadership, Change Management.
  • High Proficiency in Microsoft Office applications, especially PowerPoint.
  • PMP certification or similar project management certification.
  • Excellent interpersonal skills, both oral and written.
  • Ability to create and deliver effective presentations, tailored to the audience.
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