To pull all critical elements of a clinical trial together to ensure its successful delivery on time, within budget and to a high standard:

• Conduction of feasibility assessments and development of pilot studies
• Sample size Plan design management and execution (timelines and projections)
• Clinical trial coordination, including sample management, with storage requirements
• Arrangements for treatment allocation and labelling & distribution of trial drugs
• Launch meeting organization & conduct initiations of participating sites
• Research Team support training and schedule participant visits and follow-up, ensuring high quality of data collection
• Newsletters development & trial promotion to the Research Teams
• Maintaining study site files in accordance with GCP requirements
• Regulatory support
• Safety reporting - manage pharmacovigilance activities in accordance with regulations
• Financial and resources managementConduction of additional exploratory analyses
• Review or writing of the clinical study reports
• Assistance with sites training
• Clinical trial monitoring - conduct central and on-site monitoring
• On-going oversight & advice to participating sites
• Help identify & address barriers to timely recruitment and conduct
• Elaboration of reports for funders, regulators, sponsors
• Facilitation of audits & regulatory inspections