Safety Surveillance Research Project Manager
Provides project management support to portfolio of pre- and post-approval real-world epidemiology activities in support of product safety surveillance/evaluation.
- Supports Safety Surveillance Research colleagues in planning, and execution of studies, data queries, readouts, and regulatory responses including:
- Development and monitoring of timelines for study milestones in accordance with Pfizer SOPs
- Documentation of meeting agendas/minutes, decision logs, vendor oversight
- Document retention
- Tracking budget, invoices and payments to vendors
- Supports SSR Compliance Lead in providing oversight for studies and regulatory responses
- Provides quality control for written materials, as appropriate
- Provides oversight of milestones and coordinates with SSR Scientists to ensure compliance with milestones
- Registration of studies in the EU PAS Register
- Support development of analytics necessary to inform resourcing needs and continuity of operations
- Identifies operational efficiencies within study and response portfolio, improves systems as necessary
- Coordinates and works with other project managers within and outside of safety surveillance research to ensure tracking and consistency across SSR portfolio of studies and responses
- Assists in the definition of project scope and objectives involving all relevant stakeholders and ensuring technical feasibility
- Tracks progress on tasks and milestones. Identifies risks to milestones and deliverables, communicates, and works with study leads to mitigate accordingly
- Create and maintain comprehensive project documentation
- Understands and communicates team roles/responsibilities; helps new team members get up to speed on the project, and ensures all team members have access to project information necessary to be successful.
- Aids in the identification of team performance issues and partners with team leadership to recommend and develop appropriate actions.
- Ensures cross-functional process efficiencies are identified and maximized in accordance with team project goals.
- Excellent client-facing and internal communication skills
- Solid organizational skills including attention to detail and multitasking skills
- Demonstrated ability to build consensus
- Excellent writing and presentation skills
- Proficiency with Microsoft Office suite
- Previous experience and strong capabilities in data analytics, data tools, and Excel. Ability to define and develop new data analysis tools to meet portfolio needs.
- Ability to present oneself in a professional manner to and on behalf of SSR
- Experience with relevant project management tools (e.g. MS Project)
- Possess solid analytical, leadership, organizational and communication skills and capacity for identifying business requirements
- High level of self-motivation and ability to thrive in a goal and team oriented setting
- Bachelor’s degree or Master’s degree with experience in project management
- 3+ years’ experience providing project management support for clinical trials and/or non-interventional studies, and/or real-world data research
Other Job Details:
Last Date to Apply for Job: December 10th, 2021
Additional Location Information: New York, NY; US - Remote; Europe - Remote; Canada - Remote
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