[Remote] Project Lead/Project Manager - FSP

Note: The job is a remote job and is open to candidates in USA. Thermo Fisher Scientific is a global team that values passion, innovation, and scientific excellence. The Project Lead/Project Manager is responsible for the overall delivery of clinical trials, leading cross-functional teams, ensuring regulatory compliance, and managing project timelines and budgets.

Responsibilities

• Responsible for the delivery of the cross-functional project (time, cost, quality)​ by working closely with Global trial and functional leads
• Ensures escalation pathways adhered to internally and externally (Rules of Engagement – communication pathways)​
• On projects where the scope requires, ensures clear delineation in responsibilities and communication pathways for secondary project leads (such as lead in a specific region, lead for a specific vendor(s) or subset of delivery)
• Ensures financial stewardship at a trial level ​by demonstrating an intimate understanding of the contract, resource alignment to budget, management of Out-of-Scope activity, drive the Con Mod process/negotiations and team execution to timelines
• Establishes, communicates and manages customer expectations to achieve optimal delivery during the project​
• Drives Risk Identification and Issue Resolution at project level
• Ensures project team compliance with organization policies, SOPs, ICH- GCP, regulatory and project specific requirements​
• Responsible for vendor management, where required
• Ability to delegate and effectively prioritize own and workload of project team members in a frequently changing environment
• Effective oral and written communication and presentation skills
• Proactive, solutions oriented and adaptable to changing priorities and situations
• Advanced therapeutic area knowledge and clinical development guidelines and directives
• Sound interpersonal and customer service skills, including the ability to lead, motivate and coordinate cross-functional project teams
• Ability to negotiate, persuade and influence others, including a cross-cultural awareness

Skills

• B.A. or B. Sc. in a scientific discipline
• 6 + years in clinical operations management, managing clinical trials per quality, timeline, and budget expectations, preferably with a Sponsor company and a CRO
• Related scientific and clinical expertise and exceptional project-management, risk-assessment, contingency-planning, and communication skills
• Extensive knowledge of clinical development related to one or more trial phases (I, II, III), as well as cross-functional drug development
• Expertise in Good Clinical Practices (GCP), International Council for Harmonization (ICH) guidelines and regulatory requirements for clinical development
• Ability to establish and execute operational plans
• Technical and systems competency, such as computer skills, to include effective use of systems and applications such as Microsoft Outlook, Word, Excel and PowerPoint, as well as organization systems
• Ability to delegate and effectively prioritize own and workload of project team members in a frequently changing environment
• Effective oral and written communication and presentation skills
• Proactive, solutions oriented and adaptable to changing priorities and situations
• An advanced degree in a related field
• Investigator site and/or monitoring experience
• Functional Service Provider (FSP) experience

Company Overview

Company H1B Sponsorship