Training Modules
- Introduction to Drug Lifecycle Safety Management
- PMBOK guided Project Management broad overview of processes and knowledge areas
- Understanding the key concepts of project scope, budgets, timelines, kick off meetings (Internal and external), Go-No-Go, Business development handovers, influencing skills, Emotional Intelligence, deliverables, milestones, dependencies, predecessors, Work breakdown structures, Management plans, contingencies, planned risk responses, scheduling and forecasting, crashing, rebaseling, resource leveling, network diagrams, Gantt charts and KPIs.
- Clinical study protocol review and Clinical Safety Assessments.
- Cross-functional team interrelation and leadership strategies.
- Storytelling skills and carrying along cross functional teams and stakeholders.
- Mastering knowledge of all interdisciplinary tasks and timelines- CRC, CRA, CTA, MW, Regulatory Specialist, Pharmacist and unblinded team, Biostatistician (Blinded and unblinded), Safety specialist, Data managers etc.
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