Site Monitoring Lead

Site Monitoring Lead Clinical Trials

Location: Ridgefield, CT (REMOTE for EST and CST applicants only)

Job Description:

• 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.
• 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. Monitor clinical monitoring deliverables for assigned trials in clinical operations system(s) (e.g., BI CTMS).
• Deliver Risk-based Site Monitoring approach and local training for the trial.
• Develop and provide appropriate training of 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, as requested.
• 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 international/regional/local 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 including adherence to ICH-GCP, regulatory requirements, compliance with SOPs, trial protocol, trial quality management, and Site Monitoring plans.

Including but not limited to:

• Issue management/oversight on a country level.
• Continuous review, risk identification, evaluation/analysis, and communication on a country level as applicable.
• 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.
• Facilitate communication and training related to site monitoring in the trial at the OPU.
• Communication and training of CT Managers and CRAs. Performing re-training as necessary.
• Participate and prepare input for Trial Oversight Meetings (country level) and contribute to the timely responses to questions from external and internal stakeholders.

Requirements:

• Oncology, Metabolic, CNS, and Dermatology experience.
• Project Management, CAPA, Risk Assessment, Clinical Trial Monitoring.
• PMP Certification.

Education:

• Bachelor's Degree (Health Sciences, Health Care, Nursing, or others) required.
• 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.