Clinical Project Manager

📋 Description

• • As a Clinical Project Manager at NAMSA, you will be at the forefront of shaping the medical device industry, contributing to a legacy of innovation that began before the FDA even regulated medical products. You will play a pivotal role in guiding clients through the entire product development lifecycle, ensuring their groundbreaking medical devices reach patients safely and efficiently.
• • This role demands a strategic and hands-on approach, partnering closely with clients, cross-functional internal teams, and external subcontractors to orchestrate project execution from inception to completion. You will be the primary liaison, managing critical and high-profile client communications, adeptly resolving challenges, and knowing precisely when to escalate complex issues to management to ensure optimal outcomes for both the client and NAMSA.
• • Your responsibilities will encompass facilitating comprehensive upfront client engagement to meticulously define project scope, deliverables, timelines, and specific client communication and invoicing requirements. A key aspect of your role will be ensuring client expectations are consistently met regarding quality, schedule adherence, and budget constraints, fostering trust and long-term partnerships.
• • You will be instrumental in the seamless handover of projects from commercial teams to operations, ensuring all contractual obligations and Statements of Work (SOW) are clearly defined and agreed upon. This includes facilitating accurate and timely project setup within NAMSA's critical systems, such as SharePoint and AX, and ensuring all team members have the necessary access and resources.
• • Leading project planning will be a core function, involving the detailed definition of deliverables, schedules, budgets, resource allocation, and communication plans. You will organize and facilitate project meetings, establish scope metrics, outline work plans, clearly assign roles and responsibilities, and proactively manage project risks to mitigate potential disruptions.
• • Financial stewardship is paramount; you will manage the financial aspects of projects in strict accordance with the SOW, proactively identifying and facilitating change orders as needed to accommodate evolving project requirements while maintaining fiscal responsibility.
• • The project closure phase will be managed with the same rigor, ensuring client acceptance, conducting thorough documentation, and overseeing system closure. You will be responsible for gathering and implementing lessons learned to continuously improve project management methodologies and providing timely, constructive feedback to team members through established performance management processes.
• • You will champion and utilize NAMSA's best-practice project management tools and methodologies, actively driving improvements in capability, resource utilization, and project cycle times. This role supports simpler, single-service projects independently and collaborates with senior project managers on more complex initiatives.
• • Operating under general supervision, you will exercise a degree of latitude in decision-making and approach to responsibilities, always adhering to established procedures and quality standards. Ensuring projects are executed in compliance with Quality System (QS) requirements and applicable procedures is non-negotiable.
• • Maintaining accurate project metrics and generating comprehensive reports for management reviews will be crucial for strategic oversight. You will also play a key role in supporting client and regulatory audits, managing follow-up actions, and ensuring any client complaints are properly documented and addressed, including supporting Corrective and Preventive Actions (CAPAs) or quality initiatives to drive continuous process improvement.
• • You will actively participate in prospective and current client meetings, leveraging your expertise to identify opportunities for offering additional NAMSA services, thereby enhancing client relationships and expanding business potential.
• • Furthermore, you will provide essential project schedule, resource, and budget information to support the creation of compelling proposals, contributing directly to NAMSA's business development efforts.
• • This role offers the unique opportunity to contribute to an organization deeply committed to advancing global healthcare, improving patient lives, and accelerating client success through innovative MedTech solutions, all while upholding core values of integrity, customer experience, talent development, agility, and collaboration.