PSI Medical Monitors provide medical input to global clinical studies and advise the teams and business partners, while always focusing on patients' safety and well-being.Home-Based in MexicoResponsibilities:Acts as the primary point of contact for all parties on all trial-specific medical and safety-related questionsProvides input for responses to regulatory authorities and Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs) on trial-specific medical and safety-related questionsMonitors trial participant safetyParticipates in trial participant recruitment boost and retention activitiesPresents on medical matters at kick-off and investigator meetingsTrains trial team in the therapeutic area and medical aspects of the protocolDevelops and reviews trial-specific documents within the scope of medical monitoringManages ongoing trial risks related to medical monitoringPerforms ongoing medical review of the operational clinical trial database; provides support to Medical Reviewer(s) assigned to the trialReviews protocol deviationsReviews RAE reports, writes and/or reviews SAE narratives, supports Pharmacovigilance team with outstanding safety queries, interacts with sponsor on site safety issuesReviews IND/SUSAR Safety Reports, updates/amendments to essential trial records, and annual IND reports with sponsor data (per sponsor request)Participates in management of trial-related committees (e.g., independent data monitoring committee (IDMC)/adjudication committees) as described in the corresponding trial-specific charter(s)Supports Pharmacovigilance, Medical Data Review and Data Management with reconciliation of safety and operational clinical trial databasesReviews clinical study reports (CSRs), including safety narratives and tables, figures, and listings (TFLs)Provides medical expertise on an as-needed basis in trials where medical monitoring is not a contract deliverablePrepares for and participates in trial audits, follows up on audit findingsParticipates in feasibility assessment of potential and ongoing trials in the country/regionParticipates in bid defense meetings and other interactions with clientsActs as a medical expert and provides therapeutic expertise to other PSI departments
