Associate Manager, Program Management, Clinical Affairs

Edwards Lifesciences   •  

Irvine, CA

Industry: Business Services


8 - 10 years

Posted 413 days ago

Key responsibilities:

  • Planning: Develop detailed project plans to meet clinical objectives based on cross-functional input and analysis.
  • Through collaboration and influence, gain core team buy-in and team ownership of the plan.  
  • Scope: Understanding of Protocol writing, enrollment, monitoring, data cleaning and lock, biostats, safety, clinical submission deliverables, etc..
  • Determines and discerns requirements on larger scale projects to establish the project deliverables, and manages changes to the project scope and schedule.
  • Team Leadership: Lead cross-functional core team meetings. Build the following within the team: meeting discipline (agenda, minutes, action items) and team esprit de corps, problem solving culture and accountability.
  • Partner with project leads, cross-functional groups and other project managers to define/manage resource requirements to support project objectives.
  • Performance measurement and Risk Mitigation: Analyze performance to plan and develop corrective action plans for any variances with the core team. Identify forward looking risk and determine mitigation plans with core team.
  • Communication and Reporting: Maintain weekly status reports, including timelines and performance dashboards.
  • Maintain efficient and effective communication, per communication plan development and execution, to provide clarity for roles and responsibilities and alignment with stakeholders.
  • Serve as conduit between project/team members in all cross-functional groups (e.g. Clinical, Marketing, Ops, Quality, R&D, Regulatory, etc.)


  • Requires 8years total experience in the medical device or related industry in Project Management, Clinical and or Regulatory is preferred and 2 years’ experience specifically in Project Management.
  • A bachelor's degree is required. Previous clinical trialexperience, particularly in medical devices, is preferred.
  • Completion of project management training preferred (PMP) is a plus but not required.
  • Must be proficient in computer skills in Microsoft Project, Excel, Word, PowerPoint and Critical Chain methodology is a plus.
  • Ability to work independently and as an active member and leader of the team is essential.
  • Ability to address delicate situations and effectively manage conflict to maximize project team progress.
  • Ability to lead and motivate others to action.
  • Comfortable with a dynamic, fast paced environment.
  • Effect problem solving. Defining problems, developing solutions, weighing options and presenting recommendations.
  • Effectively communicate orally and in writing to all project stakeholders.
  • Must be able to interact with high profile investigators in a positive and constructive manner.
  • Travel  up to 10%