Site Clinical Trials Manager

hace 7 días


Buenos Aires, Buenos Aires C.F., Argentina Allergan A tiempo completo

We are seeking a highly skilled and motivated Clinical Research Associate to join our team at Allergan. As a Clinical Research Associate, you will be responsible for advancing our pipeline by striving for excellence in clinical research and leveraging new advanced capabilities to drive industry leading performance.

Responsibilities:
  • You will partner with study teams, AbbVie internal R&D stakeholders, investigators, and site staff for meaningful and effective engagements and provide contextual information on the clinical trials.
  • You will align, train and motivate the site staff and principal investigator with support as needed on the goals of the clinical trial program, protocol, and patient treatment principles for the trial.
  • You will conduct site evaluation, site training, routine on-site and off-site monitoring, and site closure activities with support as needed, in compliance to the protocol and monitoring plans and accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and to quality standards in conducting clinical research.
  • You will customize site engagement strategy for assigned study(ies) with support as needed and gather local/site insights and utilize site engagement tracking tools, to report/track progress and measure impact of that strategy.
  • You will have a fundamental level of competency connecting the study protocol, scientific principles and clinical trial requirements to the day-to-day clinical trial execution activities and evaluate and ensure effective recruitment and retention techniques/plans based on the patient disease journey.
  • You will be responsible for continuous risk-assessment proactively, and in collaboration with Central Monitoring team, monitor activities conducted by clinical sites to detect early overall study performance or patient safety issues.
  • You will identify, evaluate and recommend new/potential investigators/sites with support as needed from more experienced Site Monitors.
  • You will ensure quality of data submitted from study sites and assure timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.
  • You will ensure audit and regulatory inspection readiness at assigned clinical site at all times.


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