Accountable for the execution of monitoring plans & overall quality of monitoring performed by CRAs for assigned US conducted trials (~5-8) across Therapeutic Area(s) phase depending on complexity, size and stage of study.
Conduct on-site visits to assess CRA performance, including co-monitoring/supervisory visits, as requested, including oversight of CRAs working on assigned trials.
Implement the monitoring plan as part of the Trial Team.
Deliver Risk-based Site Monitoring approach and local training for the trial.
Behave as local expert and consultant on site management and monitoring topics.
Monitor progress and oversee Site Management and Monitoring activities conducted by CRO partners during clinical trial
Issue management / oversight on country level.
Maintain Risk-based Site Monitoring approach for the OPU and provide feedback on the trends identified that may impact the TLMM and/or site monitoring oversight plan.
Conduct Site and Monitoring Oversight (including Site Monitoring Oversight Visits) at OPU according to plan, implement follow-up actions and escalation, as required.
In conjunction with SML-r, contribute to preparation and implementation of trial level documents including training material updates/retraining as needed.
In conjunction with SML-r, facilitate communication and training related to site monitoring in the trial at the