Site Monitoring Lead

Job Title: Site Monitoring Lead

Duties:

Trial Preparation:

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. Monitor clinical monitoring deliverables for assigned trials in clinical operations system(s)(e.g. 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 (CT Manager) and Clinical Research Associates (CRA)).
• Assist with in-house Site Monitoring inspection readiness activities and lead preparation for US site regulatory inspections, as requested.
• Behave as local expert and consultant on site management and monitoring topics.
• Participate in and contribute to global/regional and local Trial Team meetings, international/ regional / local Investigator Meetings.
• 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, and regulatory requirements, compliance with SOPs, trial protocol, trial quality management and Site Monitoring plans.

Including but not limited to:

Issue management / oversight on 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.
• In conjunction with SML-r, 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, prepare input (as requested by SML-r) for Trial Oversight Meetings (country level) and contribute to the timely responses to questions from external and internal stakeholders.

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.

Skills:

• Oncology experience 
• metabolic experience 
• Dermatology experience 
• CNS experience Rem