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.