Job Title: Site Monitoring Lead
Responsibilities:
Excellent employment opportunity for a Site Monitoring Lead in the Ridgefield, CT area.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. 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 (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.
Skills:
- Oncology experience
- metabolic experience
- Dermatology experience
- CNS experience
Keywords:
- 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 and Experience:
Required Skills:
- PROJECT MANAGEMENT
- CAPA
- RISK ASSESSMENT
- CLINICAL TRIAL MONITORING
- DERMATOLOGICAL
- Additional Skills:
- CLINICAL SITE MONITORING
- ONCOLOGY
- CLINICAL MONITORING