Job Summary:Accountable for the execution of monitoring plans and 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.Key Responsibilities:Execute monitoring plans and ensure quality of monitoring by CRAs.Conduct on-site visits to assess CRA performance, including co-monitoring/supervisory visits.Implement the monitoring plan as part of the Trial Team and monitor clinical monitoring deliverables.Deliver Risk-based Site Monitoring approach and local training for the trial.Develop and provide training for local trial teams (e.g., Clinical Trial Managers and Clinical Research Associates).Assist with in-house Site Monitoring inspection readiness activities and lead preparation for US site regulatory inspections.Act as a local expert and consultant on site management and monitoring topics.Participate in and contribute to global/regional and local Trial Team meetings and Investigator Meetings.Provide timely responses to Site Management and monitoring questions from external and internal stakeholders (including Regulatory Authority/Ethics Committee).Trial Conduct:Monitor progress and oversee Site Management and Monitoring activities conducted by CRO partners during clinical trial conduct.Ensure adherence to ICH-GCP, regulatory requirements, SOPs, trial protocol, trial quality management, and Site Monitoring plans.Manage issues and oversight on a country level.Conduct continuous review, risk identification, evaluation/analysis, and communication on a country level.Maintain Risk-based Site Monitoring approach and provide feedback on trends that may impact the TLMM and/or site monitoring oversight plan.Conduct Site and Monitoring Oversight Visits at OPU according to plan, implement follow-up actions, and escalate as required.Contribute to preparation and implementation of trial level documents, including training material updates/retraining as needed.Facilitate communication and training related to site monitoring in the trial at the OPU.Participate in Trial Oversight Meetings and contribute to timely responses to questions from external and internal stakeholders.Required Qualifications:Oncology experience.Metabolic experience.Dermatology experience.CNS experience.Education:Bachelor's Degree (Health Sciences, Health Care, Nursing or Others) required with a minimum of 5 years of experience performing on-site monitoring or 8 years of relevant business experience in the regulated pharmaceutical or healthcare industry, including on-site monitoring experience. Education: Bachelors Degree