Key skills
MentoringCommunicationPresentation Skills
About this role
Role Overview
- Manage integration of project team activities
- Provide input on trial level operational strategies for clinical trials
- Input into global subject/patient recruitment plans
- Manage aspects of CRO/vendor identification
- Manage strategic study operations
- Create and update critical trial-specific documents
- Support the development of compound and protocol-level training materials
- Review and provide input into budgets, timelines, and forecasts
- Interface with internal key stakeholders
- Provide support for inspection readiness activities
- Participate in process improvement activities
- Support onboarding of new team members
- Attend CTWG and provide input on operational activities
Requirements
- BS/BA Degree required
- 5+ years of clinical research experience with a CRO, Biotech, or Pharmaceutical Company on Phase 1-4 clinical trials
- 2-3+ years leading aspects of global clinical trials
- Strong regulatory knowledge, including Good Clinical Practices (GCPs)
- Strong decision-making, analytical, and financial management skills
- Proven ability to foster team productivity and cohesiveness
- Experience in multifunctional matrixed and global environments
- Experience mentoring/coaching others
- Strong organizational skills and ability to deal with competing priorities
- Strong project planning/management, communication (written and verbal), and presentation skills
- Proficient with MS Office Suite (Excel, Word, PowerPoint)
Benefits
- Health insurance
- Flexible work arrangements
- Professional development opportunities