Clinical site monitoring lead

Found in: Appcast US C2 - 2 weeks ago

Ridgefield, United States Fladger Associates Full time

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. 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.

Experience:

  • 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.
  • Oncology experience, Metabolic experience, Dermatology experience, CNS experience
  • Required Skills: PROJECT MANAGEMENT, CAPA, RISK ASSESSMENT, CLINICAL TRIAL MONITORING, DERMATOLOGICAL
  • Additional Skills: CLINICAL SITE MONITORING, ONCOLOGY, CLINICAL MONITORING

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