Edwards has a unique opportunity to join the Transcatheter Mitral and Tricuspid Therapies (TMTT) division. As the Associate Manager, Project Management Clinical/Med PMO in TMTT, you will lead cross-functional project teams to plan, execute and achieve Clinical Trial objectives.
* 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 8 years total experience preferably in Clinical Affairs, Program Management and/or Regulatory.
* A bachelor's degree is required. Previous clinical trial experience, 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%
About Edwards Lifesciences
Edwards Lifesciences is an American medical equipment company specializing in artificial heart valves and hemodynamic monitoring.