Manage integration of project team activities
Provide input on trial level operational strategies for clinical trials
Relationship management between study sites and vendors
Manage aspects of CRO/vendor identification and day-to-day operational management activities
Manage strategic study operations including study sites and tracking systems
Create and update critical trial-specific documents
Support development of compound and protocol level training materials
Review and provide input into budgets, timelines, and forecasts for assigned clinical studies
Interface with internal key stakeholders for effective collaboration
Provide support for inspection readiness activities and risk mitigation plans
Participate in process improvement activities
Support onboarding of new team members

5+ years of clinical research experience with a CRO, Biotech, or Pharmaceutical Company working on Phase 1-4 global clinical trials
2-3+ years leading aspects of global clinical trials (CTM, COL or similar)
Experience working with a CRO
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 leading without authority in multifunctional matrixed and global environments
Experience mentoring/ coaching others
Exceptional 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 and PowerPoint)

Manager, Clinical Operations

Key skills