Associate Director, IT R&D Program Management at Radius Health in Waltham, MA

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Description


US-MA-Waltham

Job ID 2019-1949
# of Openings 1
Category IT - Dept

Overview

The Associate Director for IT R&D oversees the full project management life cycle for large, strategic projects managing activities across vendors as well as managing the implementation of smaller, tactical projects. Larger projects will require shepherding through PMO stage gates and will include management of outside vendors and staff from other departments to deliver project milestones. Smaller, tactical projects will require hands-on project management. For all projects, full transition to IT Operations will need to be defined and achieved.

Responsibilities

  • Interact directly with Research and Clinical business partners to build relationships and manage IT Programs. Manage communication with all stakeholders (business partners, IT team, service providers) in the project to ensure they are aware of the status of all work.
  • Act as a liaison among stakeholders (business partners, IT team, service providers) in delivering the Application Support. Lead communication with internal staff and 3rd party service providers to resolve issues.
  • Ensure GxP systems adhere to computer systems validation processes and procedures, including traceability matrix, validation plans and reports for IQ/OQ/PQ and UAT. Partner with key functions (e.g. Compliance, Quality, Legal, Finance, Safety, Human Resources) when appropriate to ensure solutions conform to applicable regulations.
  • Consult on business process design and data utilization for end-to-end business processes. As needed, map respective business processes (As Is - To Be) and identify instances where existing processes may be streamlined or improved prior to and/or in alignment with deploying a technology solution.
  • Promote effective use of enterprise systems across the organization.


Qualifications

  • Bachelor's degree in business, engineering, MIS, Computer Science, or related discipline is required.
  • 6+ years' project management experience in pharmaceutical or biotech industry is required.
  • Work experience with Drug Development solutions such as Regulatory Information Systems, Clinical Data Management, Statistical Analytics
  • Experience in all stages of projects, from initiation through deployment is required.
  • Experience managing projects which engage remote teams and vendors is required.
  • PMP qualifications are preferred.
  • Detailed understanding of all requirements for bio/pharma system validation with responsibility to ensure systems are compliant with FDA regulations.
  • Demonstrable knowledge of the relevant ICH, EU, and FDA guidelines and regulations for clinical trials and post-marketing environments.


PM18

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