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Global Clinical Trial Manager
2 months ago
Responsibilities:
• Planning and management of clinical studies conducted by global development team through the leadership of the cross-functional clinical study team
• Contributing to study-level risk assessments
• Leading and continually review risk mitigation activities to ensure study delivery to plan
• Identifying and resolving issues at a global level
• Collaborating with Regional Clinical Trial Manager to ensure country level study delivery aligned with global delivery plans
• Overseeing global insourcing/outsourcing partner deliverables to the required standards
• Managing study-level budget and timelines
• Leading global study-level documentation and required tool and systems set-up
• Leading development and implementation of global Drug Supply Plan
Experience:
• 1.5 – 2 years running global clinical trials with a CRO, Pharmaceutical or Biotechnology company.
• BA/BS/BSc or RN
• Ideally 7 years work experience in life sciences or medically related field, including
• Previous clinical study management/clinical project management as a study manager/clinical project manager
• Experience in overseeing external clinical research vendors (CROs, central labs, imaging vendors, etc.) highly preferred
• Project management experience including oversight of study deliverables, budgets, and timelines
• Experience collaborating and leading cross-functional teams (team/matrix environment)
• Knowledge of project risk management assessment and mitigation approaches