Medical Monitor

Medical Monitor

In this role you will be providing unbiased medical guidance to clinical sites and internal and external study operations teams. You will also be providing therapeutic and compound training, medical guidance on protocol compliance, ensuring medical congruency at subject and study level and oversight of coding of medical terms. You will be responsible for supporting clinical safety, project, and data management by reviewing critical study materials at study start up stage and data listings though the study duration. You may also assist with reviewing the interim or final data sets and the writing of the final study report. Day to day you will be in regular communication with the medical team (including medical teleconferences), and interfacing with the internal cross functional teams as well as 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 study specific 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, out of range laboratory values following study-specific laboratory guidelines and alert values (as appropriate). Review cumulative laboratory values according to the study plans.
• Review protocol deviation data and recommend protocol changes as appropriate.
• Create and follow a study-specific medical monitoring plan if applicable.
• Provide medical review of study level data, to identify gaps and areas requiring additional safety-related follow-up.
• Participate in the development, review and finalization of protocols, amendments, Clinical Study Reports, as required.
• Provide medical input into data collection tools, study plans (e.g., monitoring, statistical analysis plans, etc.).
• 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

Training

Qualifications

59,000 - 98,000 a year

Compensation details : 59000-98000 Yearly Salary

PIe7570f3ad5d7-30511-39137078