Project Manager – Early Development
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Job Description
Project Manager leading early-development clinical trials for Thermo Fisher Scientific, the world leader in serving science. Managing sponsor relationships, cross-functional delivery, finances, risks, and regulatory compliance.
Responsibilities:
- Serve as the primary contact between the sponsor and the organization at the project level
- Ensure escalation pathways are adhered to internally and externally
- Establish clear responsibilities and communication pathways for secondary project leads when required
- Lead and remain accountable for overall cross-functional project delivery across time, cost, and quality
- Demonstrate financial stewardship, including contract understanding, resource alignment to budget, out-of-scope activity management, Con Mod negotiations, and timeline execution
- Establish, communicate, and manage customer expectations for optimal project delivery
- Drive project-level risk identification and issue resolution through RBQM/RESOLVE
- Ensure project team compliance with organizational policies, SOPs, ICH-GCP, regulatory requirements, and project-specific requirements
- Lead, motivate, and coordinate cross-functional project teams
Requirements:
- Bachelor's degree or equivalent and relevant formal academic/vocational qualification
- 8+ years of comparable experience providing the knowledge, skills, and abilities to perform the job
- Technical and systems competency, including Microsoft Outlook, Word, Excel, PowerPoint, CTMS, Preclarus, and Clarity
- Ability to delegate and prioritize personal and project-team workloads in a frequently changing environment
- Effective oral and written communication and presentation skills
- Advanced therapeutic-area knowledge and knowledge of clinical development guidelines and directives
- Strong understanding of project-management principles covering time, quality, and cost, including financial acumen
- Sound interpersonal and customer-service skills
- Ability to lead, motivate, and coordinate cross-functional project teams
- Good judgment, decision-making, critical-thinking, analytical, and strategic-thinking skills
- Ability to manage complex or ambiguous situations
- Ability to negotiate, persuade, and influence others
- Cross-cultural awareness
- Ability to comply with organizational policies, SOPs, ICH-GCP, regulatory requirements, and project-specific requirements
- Ability to work in environments involving potential exposure to biological fluids and infectious organisms
- Ability to use required personal protective equipment, including protective eyewear, garments, and gloves
Benefits:
- Collaboration and development as part of the everyday experience
- Reasonable accommodation for individuals with disabilities during the application/interview process and to perform essential job functions
- Equal employment opportunity
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