rochesternewyork | Sr Project Manager - CSV/21 CFR Part 11 in Tarrytown, NY

Sr Project Manager - CSV/21 CFR Part 11

  • NCS Technologies
  • Tarrytown, NY 10591
  • Full-Time
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Sr. Project Manager with heavy pharma background. Validation process experience is very important. Understanding the CSV process is a critical skill for the PM . For details please contact Christine Lippelt 732 ### #### ext 308 Solid PM with former Pharma Bio Tech Experience ClingRegulatory or CSV21 CFR Part 11 experience. Understanding the CSV process is a critical skill for the PM . Experienced in an RDClinical environment. Interpersonal Soft Skills very important. Sr. Technical Project Manager with experience to oversee and manage enhancements to a few different initiatives Manage process from RFP through implementation as well as some projects that are enhancements to existing systems. They use Planview for Project Tracking, reporting and financials. 5 years of progressive experience in IT project management 3 years resource management experience 3 years experience working with and managing vendors and partners 3 years project budget management Preferred Pharmaceutical or biotech experience Advanced degree Plus but not required - (MBA, Masters in Operations Research or similar discipline) PMP or Prince2 certification - Plus but not required Experience with growth-stage companies Experience with the Planview PPM tool and reports Experience in one or more of the following Business Units Clinical Development, Biostatistics and Data Management, Medical Affairs, Medical Writing, Regulatory Affairs, SafetyPharmaco Vigilance, Risk Management JOB DUTIES List essential (6-10) to be performed. These are the most critical responsibilities bull Work closely with the Program Manager, Portfolio Director and PMO Operations to identify and promote best practices and continuous improvement in PMO processes, systems, tools and reports bull Understand the objectives and requirements, both at a high level and a detailed level, to provide continuity of vision and understanding across the team throughout the full lifecycle of the project bull Author and ensure the quality and on time delivery of PMO artifacts related to the project, as well as timely execution of SDLC gate check processes bull Accountable for project budgets, forecasts, revisions, and project-related accruals bull Build the Project Charter, which should include the resource plan and roles, the communication plan, a description of major features or work products, lists of major milestones, potential risks, and project dependencies, and the project budget bull Work with the BRM to ensure that the Project Charter clearly defines the business objectives and measures of success, and ensure that the team understands this during program kick-off bull Expanding on the project charter, build-out and manage to a Project plan including tracking of key project milestones, (e.g., specify goals, strategy, staffing, scheduling, identification of project risks and dependencies, issue resolution processes, contingency plans, and change controls) bull Manage the delivery team (andor vendorrsquos delivery team), ensuring that team members deliver quality work on time and on budget while rigorously managing scope and delivering the expected value proposition bull Anticipate challenges, track and actively manage dependencies, issues and risks and escalate as appropriate to the Program Manager or Portfolio Director bull Provide weekly status and work with the Program Manager, the Portfolio Director and the BRM to provide client and stakeholder transparency and project level reporting bull Organize and facilitate UAT of applications with the assistance of the BRM (responsible for providing business-side UAT resources) and directly participate in early UAT to ensure readiness JOB REQUIREMENTS List knowledge, skills, and abilities required to perform the job. List any preferred job requirements as well. Required Knowledge and Experience bull Solid understanding of Project Management Office, SDLC and governance best practices bull A track record of high quality, successful, on time and on budget delivery of major projects bull Budget management and financial reporting experience bull Sound business acumen and client-focus Leadership bull Proven ability to establish and maintain strong long-term relationships, communications and interact professionally with a diverse group of Executives, Managers, and Subject Matter Experts in both IT and business unit groups bull Passion for managing change, as well as achieving high quality results bull The demonstrated ability to effectively organize, influence and motivate diverse teams to achieve goals bull Experience commanding status meetings and effectively holding team members accountable for status, deliverables and timely escalation of blockers bull A history of successfully managing vendors and vendor-implemented packaged software Collaboration bull Collaborate closely with Business Analysts, Solution Architects and Application Quality Assurance to provide continuity and promote a consistent understanding of the business requirements and objectives throughout the full lifecycle of the project bull Actively anticipate, track and plan for project risks and issues, dependencies, and resourcing (working closely with the Program andor Portfolio Director on cross-team dependencies and impacts) bull Function as a trusted advisor to the Program Manager andor Portfolio Director and the Business Relationship Manager o Build strong relationships and gain trust o Understand business requirements, values and goals o Communicate changes in status, risks, issues and dependencies quickly bull Work closely with the Program Manager andor Portfolio Director and Business Relationship Manager on client and stakeholder communication and reporting bull Escalate issues that are blocked to the Program Manager andor Portfolio Director in a timely manner Innovation bull Demonstrate an analytical, objective, and strategic mindset bull Analyze processes and systems, identify potential for change and champion opportunities for improvement, with the assistance of the Program Manager andor Portfolio Director bull Possess a solid understanding of previous technology solutions implemented and bring that passion for technology to this role as well SkillsTools bull Familiarity with commercial Project and Portfolio Management (PPM) tools and reports bull Expertise with MS Project and MS Office Suite Required bull 5 years of progressive experience in IT project management bull 3 years resource management experience bull 3 years experience working with and managing vendors and partners bull 3 years project budget management Preferred bull Pharmaceutical or biotech experience bull Advanced degree (MBA, Masters in Operations Research or similar discipline) bull PMP or Prince2 certification bull Experience with growth-stage companies bull Experience with the Planview PPM tool and reports bull Experience in one or more of the following Business Units Clinical Development, Biostatistics and Data Management, Medical Affairs, Medical Writing, Regulatory Affairs, SafetyPharmaco Vigilance, Risk Management
Associated topics: chief program officer, cpo, manage, manager, management, monitor, product manager, project manager, relationship manager, task


* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.