Job Summary:

The Site Monitoring Lead is responsible for overseeing and executing monitoring plans, ensuring the quality and compliance of clinical monitoring activities for assigned clinical trials in the US. This role will supervise the performance of Clinical Research Associates (CRAs) and collaborate with trial teams to ensure that trials are conducted in adherence to regulatory requirements, Good Clinical Practice (GCP), and company standards. The Site Monitoring Lead will contribute to the overall trial conduct, including site monitoring, risk management, and training efforts, while ensuring the timely execution of trial deliverables.

Key Responsibilities:

• Accountable for executing monitoring plans and ensuring the overall quality of monitoring performed by CRAs for assigned US trials (5-8 trials, depending on complexity and phase).
• Conduct on-site visits to assess CRA performance, including co-monitoring and supervisory visits, and provide oversight of CRAs working on assigned trials.
• Oversee site management and monitoring activities performed by CRO partners to ensure compliance with ICH-GCP, regulatory requirements, SOPs, trial protocol, and site monitoring plans.
• Implement a risk-based site monitoring approach in alignment with the trial team’s goals and deliverables.
• Continuously assess risks at the country level, identifying, evaluating, and communicating risks that may impact trial conduct.
• Conduct Site Monitoring Oversight Visits at the OPU according to plan, ensuring corrective actions and escalations are performed as needed.
• Develop and provide training to local trial teams, including Clinical Trial Managers (CTMs) and Clinical Research Associates (CRAs), ensuring they are equipped to execute site monitoring and site management plans effectively.
• Facilitate ongoing communication and retraining of trial teams related to site monitoring activities as needed.
• Support in-house site monitoring inspection readiness activities and lead the preparation for US site regulatory inspections, as requested.
• Act as a local expert and consultant on site management and monitoring, providing guidance to internal and external stakeholders (including regulatory authorities and ethics committees).
• Respond in a timely manner to site management and monitoring-related questions, ensuring stakeholders are provided with the necessary information and support.
• Collaborate with the Site Monitoring Lead (SML-r) in the preparation and implementation of trial-level documents, including training material updates and revisions.
• Provide input for Trial Oversight Meetings at the country level and contribute to ensuring all trial-related concerns are addressed promptly.
• Lead issue management and oversight at the country level, monitoring site performance and supporting the timely resolution of issues.

Qualifications:

• Bachelor’s degree in Health Sciences, Nursing, or related field is required.
• Minimum of 5 years of experience in clinical operations with at least 3 years of experience performing on-site monitoring.
• 8 years of relevant business experience in the pharmaceutical or healthcare industry, including on-site monitoring experience.
• Experience in monitoring clinical trials in Oncology, Metabolic, Dermatology, and/or CNS therapeutic areas is preferred.
• Strong knowledge of ICH-GCP, regulatory requirements, and site monitoring practices.
• Ability to lead and manage a team of CRAs and other clinical professionals effectively.
• Expertise in risk-based site monitoring approaches and issue resolution.