Global Project Manager - Study Close-out (FSP), US (Remote)

Thermo Fisher Scientific • Wilmington, NC

1d • Remote

About The Position

Join Us as a Project Manager - Make an Impact at the Forefront of Innovation The Project Manager serves as the Global Project Lead embedded within the sponsor team and is accountable for the overall delivery of the project (quality, time, cost) on behalf of the organization. Additionally, the Project Manager establishes and communicates customer expectations to the project team and ensures that escalation pathways are adhered to internally and externally. The role involves leading the cross functional project team to meet or exceed deliverables. This role focuses on Asset Wind Down and Study Close-out activities. What You'll Do: Serve as the Global Project Lead embedded with the sponsor team. Ensure escalation pathways adhered to internally and externally (Rules of Engagement – communication pathways). On projects where the scope requires, ensure 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). Accountable for the overall delivery of the cross-functional project (time, cost, quality). Ensure financial stewardship at a project 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. Establish, communicate and manage customer expectations to achieve optimal delivery during the project Drive Risk Identification and Issue Resolution at project level Ensure project team compliance with organization policies, SOPs, ICH- GCP, regulatory and project specific requirements.

Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• 5+ years’ experience in pharmaceutical industry and/or clinical research organization, including 3+ years clinical study management/oversight, including significant study management support experience (e.g., clinical trial assistant/associate or lead CRA).
• Experience could include either early phase clinical studies or Phase 2 and 3 studies and global/international studies or programs. Experience in more than one therapeutic area is advantageous.
• Extensive Global Study Close-out experience as a Project Lead required
• Extensive Vendor Management experience required
• Technical and systems competency, such as computer skills, to include effective use of systems and applications such as Microsoft Outlook, Word, Excel and PowerPoint, etc.
• 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
• Strong understanding of the key principles of project management (time, quality, cost), including solid financial acumen
• Sound interpersonal and customer service skills, including the ability to lead, motivate and coordinate cross-functional project teams
• Good judgment and decision-making skills and capable of applying critical and analytical strategic thinking skills to manage complex/ambiguous situations
• Ability to negotiate, persuade and influence others, including a cross-cultural awareness.

Nice To Haves

• Experience in more than one therapeutic area is advantageous.

Responsibilities

• Serve as the Global Project Lead embedded with the sponsor team.
• Ensure escalation pathways adhered to internally and externally (Rules of Engagement – communication pathways).
• On projects where the scope requires, ensure 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).
• Accountable for the overall delivery of the cross-functional project (time, cost, quality).
• Ensure financial stewardship at a project 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.
• Establish, communicate and manage customer expectations to achieve optimal delivery during the project
• Drive Risk Identification and Issue Resolution at project level
• Ensure project team compliance with organization policies, SOPs, ICH- GCP, regulatory and project specific requirements.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees