Senior ICF Project Manager
Job Summary
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
Join Us as a Senior Informed Consent Form (ICF) Project Manager (PM) Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs spanning 2700 clinical trials across 100 countries in the last 5 years.
As part of our expert team youll have the opportunity to ensure operational excellence that makes a real difference in organizational performance. As a Senior ICF PM you will lead patient-centric medical writing projects with a primary focus on ICFs through collaboration with internal and client teams. You will manage project timelines budgets and resources ensuring the timely delivery and quality of individual projects and documents for internal and external clients. You will build client relationships and identify and resolve client management issues. Additionally you will develop monitor and adapt project plans timelines and budgets/forecasting for assigned projects.
What Youll Do:
Develop project timelines standards budgets forecasts and contract modifications for assigned projects. Serves as liaison with other departments on contract modifications.
Collaborate with cross-functional team members as needed to meet the deliverables of the project. Regularly communicates with the team and leads team meetings to ensure that timelines resources and quality are maintained.
Ensure achievement of final deliverables within the contractual time period by preparing and monitoring timelines providing status updates to the appropriate point of escalation and regularly reviewing projects using tracking and management tools.
Evaluate and appropriately escalate or resolve risks to project quality budget or timeline.
Ensure compliance with quality processes and requirements for assigned projects both within and between documents within a project. Review and manage performance metrics for assigned projects.
Education and Experience Requirements:
BS/BA (scientific discipline preferred) with at least 5 years relevant experience or an advanced degree with at least 3 years relevant experience
Previous experience that provides the knowledge skills and abilities to perform the job (comparable to 5 years).
Experience in managing medical writing or clinical projects required. Experience managing ICF content is advantageous.
Experience working in the pharmaceutical/CRO industry preferred.
Experience in medical writing (eg Regulatory and/or plain language) advantageous
Years of experience refers to typical years of related experience needed to gain the required knowledge skills and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions.
Knowledge Skills and Abilities:
Strong project management skills to include budgeting forecasting and resource management.
Solid planning and organizational skills to enable effective prioritization of workload.
Excellent interpersonal skills including problem solving judgment and decision-making skills; self-motivated and adaptable
Effective oral and written communication skills with internal and external stakeholders; strong negotiation skills
Good knowledge of global regional national and other regulatory and document development guidelines relevant to patient-centric deliverables.
Good judgment; high degree of independence in decision making and problem solving
Working Conditions and Environment:
Work is performed in a remote office environment with exposure to electrical office equipment.
Why Join Us
When you join Thermo Fisher Scientific you become part of a global team that values passion innovation and a commitment to scientific excellence. Youll work in an environment where collaboration and development are part of the everyday experienceand where your contributions truly make a difference.
Apply today to help us deliver tomorrows breakthroughs.
Required Experience:
Senior IC
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more