[Remote] Project Manager

Note: The job is a remote job and is open to candidates in USA. NAMSA is a pioneering company in the medical device materials industry, focusing on safety and regulatory compliance. The Project Manager will partner with clients and cross-functional teams to manage project execution throughout the lifecycle, ensuring client expectations are met for quality, schedule, and budget.

Responsibilities

• Partner with the client , cross-functional team and sub-contractors to effectively staff and manage project execution throughout the entire project life cycle
• Serve as key liaison with client, including communications in critical and high-profile discussions
• Resolve or de-escalate challenging situations with the client, and know when to escalate issues to management
• Ensure a balance of both the client and NAMSA business needs
• Facilitate up-front client engagement to establish project scope, deliverables, timeline, client requirements for communication, invoicing etc. and ensures client expectations are met for quality, schedule and budget
• Facilitate project handoff from commercial to operations with signed SOW
• Facilitate accurate and timely project set-up and team access in applicable systems, including SharePoint, AX, and project specific systems
• Lead project planning of deliverables, schedule, budget, resources, communications, organize and facilitate meetings, scope metrics , outline workplan, identify and assign roles & responsibilities and risk management
• Manage financial aspects of the projects according to the statement of work and facilitate change orders as needed
• Lead project closure with client acceptance and survey, documentation and system closure
• Gather and take action on lessons learned as applicable. Provide timely feedback on team members using the appropriate performance management processes
• Utilize NAMSA project management best practices and tools, and drive improvements in capability, utilization, and cycle time
• Support simple single service projects with minimal cross-functional interaction or supports senior project managers with complex projects
• Work under general supervision and follows established procedures with some latitude in decision making and approach to responsibilities
• Ensure projects are executed following QS requirements and applicable procedures
• Maintain project metrics and reporting for management reviews
• Support client and regulatory audits and follow-up
• Ensure any complaints are filed including the support of CAPAs or quality initiatives as needed for quality and process improvement
• Participate in prospective and current client meetings and identify opportunities to offer additional services for clients during engagements
• Provide project schedule, resource, and budget information as needed to support creation of proposals
• Other duties as assigned
• Performs other duties as assigned

Skills

• Bachelor's degree in a related field required or equivalent
• Minimum of 3 years of experience in medical device, clinical, regulatory or related field required
• At least 1 year Project Management experience required
• Demonstrated execution of project management tools, processes, practices and procedures
• Proficient with MS Project or similar and SharePoint
• Ability to understand and navigate the complexity of multiple moving activities, competing priorities, and limited resources
• Ability to persuasively influence client and internal stakeholders to ensure high quality deliverables are completed on time and budget
• Strong verbal and written communications skills, with the ability to motivate, influence, and negotiate
• Excellent time management, organization, and project management skills
• Effective analytical and problem solving capabilities, with the ability to translate complex problems to be easily understandable
• Understanding of project financials and impact to the business
• Understanding of technical project components and impact on other technical project areas
• Ability to work in a highly matrixed team environment
• Ability to train and mentor others
• MBA or Advance degree preferred
• Advanced Certification in a relevant program such as project management, clinical research, six sigma, lean, or similar program preferred
• Experience with Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and Good Manufacturing Procedures (GMP) preferred

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