Note: The job is a remote job and is open to candidates in USA. Thermo Fisher Scientific is a global team committed to scientific excellence, innovation, and collaborative development. The Project Manager will lead early development clinical projects as the primary sponsor contact, managing cross-functional delivery across quality, time, cost, financial stewardship, customer expectations, risk resolution, and regulatory compliance.
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)
- 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 (RBQM/RESOLVE)
- Ensure project team compliance with organization policies, SOPs, ICH- GCP, regulatory and project specific requirements
Skills
- Position REQUIRES Project Management experience with early phase trials in clinical pharmacology (normal healthy volunteers) and/or Ph 1b trial experience to be considered
- 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 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
- Work is performed in an office/ laboratory and/or a clinical environment
- Exposure to biological fluids with potential exposure to infectious organisms
- Exposure to electrical office equipment
- Personal protective equipment required such as protective eyewear, garments and gloves
Benefits
- Remote work arrangement
- An environment where collaboration and development are part of the everyday experience
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