IT Program Director – Clinical Research, Medical Study and Regulatory Affairs – Medtronic – Mounds View, MN

Careers that Change Lives

POSITION DESCRIPTION:

The Medtronic IT Business Partnership Services Organization is looking for an IT Program Director to establish, execute and drive the governance of multiple critical programs for enterprise function of Clinical Research, Medical Study, and Regulatory Affairs (CMRA). These programs provides pre/post market trials and studies, data capture and reporting, publishing/submission to regulatory bodies for all OUs and regions across. This role will establish and manage the program across Medtronic IT interests spanning business unots and regions. This role will be responsible for the successful execution of all IT-related projects and maintain appropriate governance arrangements to ensure the successful implementation of the desired outcomes. The IT Program Director will have oversight of all IT projects within related programs to ensure inter-dependencies and tasks are identified and delivered to achieve the desired goals. Advanced organization, communication and leadership skills are needed to manage the following key activities:

  • Business case and benefits management
  • Stakeholder management and communications
  • Risk management and issue resolution
  • Planning and control
  • Quality management
  • Organizational development
  • Program and project decomposition

POSITION RESPONSIBILITIES:

  • Serve as the strategic advisor to the R&D, Clinical, and Regulatory business functions and partner with business program leaders globally
  • Provide critical leadership to ensure overall quality of project planning and execution, while minimizing and mitigating project risks by collaborating with senior level executives across the organization
  • Initiate goal setting for cross-functional programs and projects according to the strategic objectives of Medtronic IT
  • Understand and drive the need for transformation, timely decision making and change management throughout the lifecycle of an initiative, across all interrelated projects:
  • Plan and manage programs from start to completion (deadlines, milestones, processes, organization design improvements and organization change).
  • Establish program level governance leveraging processes to identify, assess, review and present all Change Requests to governance groups.
  • Provide consistent and timely communication to ensure leaders remain aware, aligned and engaged with transformation.

Identify and manage program scope across several inter-related projects, including the following key activities:

Prepare impact analysis against scope, schedules, and budget

  • Identify, review and present all change requests to governance groups
  • Prepare a risk management plan across the program.
  • Ensure quality of all program and project outcomes, deliverables, and products
  • Comply with all corporate policies, standards, procedures, and processes
  • Create, maintain, and report business case and benefits realization plan
  • Collaborate with finance to develop the ROI and manage the financial cost modeling
  • Establish best practices for developing, implementing, and maintaining IT system processes for business demands
  • Direct initiatives to identify, prioritize, define, and implement improvements to the global commercialization process to achieve best-in-class status
  • Create, maintain and report against a cross project schedule and resource management plan, including:
  • Accountable for overall program delivery across all inter-related projects
  • Liaise with key Stakeholders and implementation resource groups to ensure alignment of priorities
  • Provides partnership and feedback to the design control facilitators
  • Provide critical leadership to ensure overall quality of project planning and execution, while minimizing and mitigating project risks
  • Identify, mitigate and review Risk and Issue Logs
  • Assume ownership for all program level risks and issues
  • Assume ownership for all critical project level risks and issues
  • Ensures adequate project and team training to core teams.
  • Provide coaching and leadership to Project Manager(s) with the program
  • Coaches team members to ensure process adherence and effective project management, utilizing best practice project management skills, as well as framing and resolving issues through best practices.
  • Establish and maintain reporting standards in line with steering committee and project sponsors needs
Must Have: Minimum Requirements

  • Bachelors degree required
  • Minimum of 10 years of relevant IT experience with 7+ years of managerial experience, or advanced degree with a minimum of 8 years of relevant IT experience with 7+ years of managerial experience

Nice to Have

  • Proven experience as program director or other managerial position
  • Broad knowledge of program management principles, techniques and methodologies
  • Familiar with software selection, RFP management, change management and large scale technology deployment
  • Self-starter – Plan the programs from start to completion
  • Discover ways to enhance efficiency and productivity of procedures and people
  • Working knowledge of MS office and program management software
  • Excellent organizational and leadership skills
  • An analytical mindset with great problem-solving abilities
  • Excellent communication skills and story telling experiences with executive audience
  • Experience influencing teams across multiple business stakeholders
  • Experience managing system implementation vendors on large programs
  • Life science and regulatory systems experience
  • Highly organized with financial management experience
  • More than 5 years of experience in Program Management and Delivery
  • Agile delivery framework
  • Complex projects of more than $10M budget
  • Full project lifecycle and a minimum of 3 complex projects of more than 2-year duration
  • Business case development and measurement
  • Medical Device product development experience
  • Driving Strategic Alignment
  • Proven knowledge of developing and implementing strategic goals
  • People Leadership
  • Direct supervisory responsibility
  • Resource planning experience
  • Matrix team management responsibilities
  • Negotiation and Facilitation skills
  • Proven steering group management skills
  • Data management and/or software engineering experience
  • Advanced level of competency in Microsoft Project, Microsoft Project Server and Microsoft Office
  • Advanced Degree
  • Program Management Qualifications, e.g. Managing Successful Programs (MSP) or equivalent
  • Risk Management Qualifications, e.g. Management of Risk (MoR) or equivalent
  • PgMP Certification

About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations – but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

Physical Job Requirements

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)

Source: Indeed.com
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