Global Project Manager - Study Close-out (FSP), US (Remote)
- 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.
- 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.
- Exposure to electrical office equipment.
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