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