Hiring company: Edwards Lifesciences
Edwards has a unique opportunity to join the Transcatheter Mitral and Tricuspid Therapies (TMTT) division. As Senior Analyst, Project Management, you lead cross-functional project teams to plan, execute and achieve Clinical Trial objectives.
Key responsibilities:
- Actively leads multiple Project Management Office (PMO) continuous improvement activities
- Planning: Develop detailed project plans to meet clinical, medical and regulatory optimization, standardization and process efficiency 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, trial enrollment, monitoring, data management, data cleaning and lock, biostatistics, safety, clinical submission deliverables, regulatory 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, Medical, Marketing, Ops, Quality, R&D, Regulatory, etc.)
- This position meets the definition for a patient-facing or in-hospital role
Basic Qualifications
- Bachelor’s degree
- Minimum 5 years of experience working in a clinical setting or the medical device industry within project management, clinical or regulatory and at least 2 years of project management experience
Preferred Qualifications
- Clinical trial experience, particularly within the medical device industry
- Completion of project management training preferred (PMP)
- Must be proficient in computer skills in Microsoft Project, Office, Excel, Word, PowerPoint and Critical Chain methodology
- Ability to work independently and as an active member/ leader of the team is essential.
- Ability to address delicate situations and effectively manage conflict to maximize project team progress.
- Ability to proactively escalate issues to appropriate levels of management in the organization
- 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.
- Ability to facilitate the creation and approval of business cases and utilizes historical data and expert judgment to understand project limitations.
- 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.
- Proficient presentation skills and ability to effectively interact with leadership is critical in this role.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all patient-facing and in-hospitals positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who enter a hospital or healthcare facility as part of their role. If hired and your position meets this criteria, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19 or have a valid religious or medical exemption from being vaccinated.