Senior Clinical Project Manager - Cell & Gene Therapy
On-site · Durham, North Carolina, United States
Job Summary
Senior Clinical Project Manager leading Cell & Gene Therapy global and domestic projects, accountable for delivering scope, schedule, budget, and quality; serves as key client contact, directs cross-functional teams, manages risk and change control, ensures regulatory data quality, and may have line management and business development responsibilities; requires working knowledge of drug development and clinical trial execution, 7+ years of clinical research experience in pharma/CRO, and ICH/GCP proficiency.
Required Qualifications
- University/college degree (life science preferred) or certification in a related allied health profession (i.e., nursing, medical or laboratory technology) from an appropriately accredited institution
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements
- Minimum of seven (7) years of relevant clinical research experience in a pharmaceutical company/CRO
- including at least two (2) years of full project management responsibility
- Working knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs
- Advanced computer skills (e.g., Microsoft Word, Excel, Project, Access, and Power Point)
- Experience managing projects in a matrix and virtual environment
- Excellent communication, planning, and organizational skills
- Demonstrated ability to lead by example and to encourage team members to seek solutions independently
- Demonstrated ability to handle multiple competing priorities and to utilize resources effectively
- Demonstrated ability to inspire effective teamwork and motivate staff within a matrix system
- Financial awareness and ability to actively utilize financial tracking systems
- Good knowledge of project management processes
- Ability to work independently and mentor junior project team members
- Ability to negotiate and liaise with clients in a professional manner
- Ability to present to staff at all levels
- Preferred Qualifications Include: Master’s or other advanced degree PMP certification
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