Project Management

Our project managers have more than 12 years of clinical trials experience and project management, including in regional and global clinical trials. Our scope of project management services includes:

  • Project planning and reporting;
  • Project measurement agreed by Key Performance Indicators (KPIs);
  • Primary point of contact to lead, manage and coordinate the conduct of clinical trials from study design to close out at a global level in accordance with ICH-GCP;
  • Oversee the quality and scientific integrity of clinical operations for studies at a regional and/or global level;
  • ¬†Collaborate with cross-functional stakeholders to ensure timeline and on budget execution of clinical trial deliverables;
  • Manage vendors, review vendor budgets and scope of work and liaise with the vendors for any study-specific issues or queries;
  • Lead and continually review risk mitigation activities to ensure study delivery to plan;
  • Collaborate with Global and/or Regional Managers to ensure country level study delivery aligned with global delivery plans;
  • Lead the cross-functional study team to ensure the studies are delivered on time;
  • Review data flow and expected data set, identify trends and provide support to monitors and sites to improve data flow;
  • Maintain study budgets and coordinate any change orders required;
  • Lead global study-level documentation and required tool and systems set-up;
  • Lead development and implementation of global Drug Supply Plan;
  • Oversee global insourcing/outsourcing partner deliverables at the required standards.