Accountable for all aspects of assigned clinical trials.
Lead the Clinical Trial Team, who is responsible for planning, conducting and reporting of clinical trials.
Author robust protocols with scientific rigor and quality.
Trial conduct must be efficient, with seamless execution and timely reporting.
Lead and matrix manage the global multidisciplinary Clinical Trial Team (CTT) who is responsible for planning, conducting and reporting on all clinical trials within CDMA. Each Clinical Trial Lead, leads 2 to 3 clinical trial teams for studies of low to medium complexity in support of one or more projects.
Contribute feasibility input for the development of the protocol synopsis. Collaborate with the Medical Advisors to ensure country feedback is adequately integrated into the protocol.
Independently ensure quality and timely execution of a clinical trial within timeline and budget.
Accountable for the development, management and tracking of trial budget.
Accountable for accuracy of trial information in all trial databases and tracking systems
Write scientifically rigorous protocols aligned with the approved protocol synopsis
Lead CTT to select countries and sites
Ensure investigational product supply
Ensure Health Authority and IRB/IEC submission and approval
Ensure all auxiliary documents, including manual of procedures, informed consent template, investigator brochure, statistical analysis plan, data validation plan, etc. are written in high quality and available.
Define clinical outsourcing specifications and scope of work for clinical trial vendors. Oversee conduct of tasks.
Ensure implementation of standard data collection modules, where possible or obtains approval for deviation.
Source: Job Diva – Job Listing