(Sr) Project Manager - eCOA/Rater Oversight - Remote based in the US

Thermo Fisher Scientific is a global leader in scientific innovation, and they are seeking a Senior Project Manager to lead global clinical trial projects. The role involves managing cross-functional teams, ensuring regulatory compliance, and delivering high-quality results in clinical development.

Responsibilities:

• Serve as the primary contact between the sponsor and the organization at the project level
• 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)
• Drive and own 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 (RBQM/RESOLVE)
• Ensure project team compliance with organization policies, SOPs, ICH- GCP, regulatory and project specific requirements
• Act as a mentor
• Develop or contribute to process improvement initiatives

Requirements:

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years')
• 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 (CTMS, Preclarus, Clarity)
• Ability to delegate and effectively prioritize workload and resources for project team members in a frequently changing environment
• Effective oral and written communication and presentation skills
• Proactive, solutions oriented and adaptable in changing priorities and situations
• In-depth therapeutic area knowledge and clinical development guidelines and directives
• Advanced knowledge of the key principles of cross functional project management (Time, Quality, Cost)
• Effective interpersonal including the ability to lead, motivate and coordinate cross-functional project teams
• Strong customer service skills with the ability to proactively address and prioritize expectations
• Good judgment and decision making skills and proven ability to apply critical and analytical and strategic thinking skills to manage complex/ambiguous situations
• Strong negotiation skills with ability to influence others and achieve results, including a cross cultural awareness
• Strong financial acumen with the knowledge and ability to minimize risk by proactively managing and adjusting budgets/forecasts/resources
• Ability to work independently with minimal supervision