Job Title

In this role you will be providing unbiased medical guidance to clinical sites and internal and external study operations teams. You will also provide therapeutic and compound training, medical guidance on protocol compliance, ensure medical congruency at subject and study level, and oversight of coding of medical terms. You will support clinical safety, project, and data management by reviewing critical study materials at study startup and data listings throughout the study duration. You may assist with reviewing interim or final data sets and writing the final study report. Daytoday you will communicate regularly with the medical team (including medical teleconferences) and interface with internal crossfunctional teams and sponsor medical groups throughout the study. Medical Oversight Provide clarity on general protocol questions, and medical guidance for protocols as required Serve as medical expert providing guidance on patient eligibility, and investigational product related questions Document contacts in accordance with Alimentiv or studyspecific procedures Consult with Alimentiv Medical Director(s), Sponsor Medical group and/or Safety about medical questions pertaining to the indication/compound under study Observe and identify safety issues and other trends as appropriate Provide consultation on the unbinding of trial participants/site staff to subject treatment allocation Review individual outofrange laboratory values following studyspecific laboratory guidelines and alert values; review cumulative laboratory values according to the study plans Review protocol deviation data and recommend protocol changes as appropriate Create and follow a studyspecific medical monitoring plan if applicable Provide medical review of studylevel data to identify gaps and areas requiring additional safetyrelated followup Participate in the development, review, and finalization of protocols, amendments, Clinical Study Reports, as required Provide medical input into data collection tools and study plans (e.g., monitoring, statistical analysis plans) Provide medical input into study feasibility, site selection and site initiations as required Attend and lead medical monitoring teleconferences at regularly scheduled intervals throughout the study, if required Knowledge Maintain thorough knowledge of protocol(s) and the current Investigator Brochure(s) with particular attention to safety data involving human subjects Training Participate in the development and maintenance of medical educational materials Provide internal training to Alimentiv operational teams on specific diseases, drug targets, pharmacology, protocol requirements, etc., as needed to support execution of client studies or general acquisition of appropriate medical knowledge as required by the organization Assist with the development of investigator training and meeting support materials Attend and present at investigator meetings and CRA training meetings Qualifications Medical degree with a strong understanding of the drug development process, ICH, and Good Clinical Practices; typically about 46 years of related experience with substantial ongoing jobrelated training Strong written and verbal communication and presentation skills, enabling effective interactions with team members within Alimentiv, client company personnel, and prospective sponsors Ability to exercise sound clinical judgment in addressing protocol ambiguities and unforeseen medical scenarios that arise during trial conduct; strong analytical and critical thinking skills are essential for identifying safety signals, evaluating complex patient data, and recognizing emerging trends across study populations to ensure subject protection and data integrity Previous experience in clinical trials is preferred, especially in navigating complex medical scenarios within a CRO environment Fluent in English #J-18808-Ljbffr