Medical Monitor - Hepatology- Part Time

Contract Medical Monitor Part-time/ad hoc -- needed about 4-5 hrs/week or 20-25 hrs/month

Fully Remote Duties are full-scale Medical Monitor -- SAE narratives; trends, data analysis, consulting with PI about patients cases for a NASH study US Medical degree --; but will accept foreign MD if have true US Med Monitor experience Need experience NASH specifically Job

Description/Job Duties:

• Review safety reports generated by COMPANY data management team (e.g., adverse events by highest severity and relationship, laboratory and vital signs data integration with adverse events) Responsible for ongoing monitoring of reports of adverse events/SAEs submitted by the clinical sites to ensure good clinical practice and to identify safety concerns quickly.
• The SAE evaluations by the medical monitor are usually blinded to treatment assignment. Provide Medical review of study level data and participate in an editorial capacity in the development, review and finalization of study narrative summaries, Clinical Study Reports and publications in conjunction with Medical Writing Group.
• Provide Medical review of study level data and participate in an editorial capacity in the development, review and finalization of study narrative summaries, Clinical Study Reports and publications in conjunction with Medical Writing Group.
• Knowledge of ICH/GCP/FDA regulations and guidelines At least 3 years drug development experience in Pharma, Biotech, CRO industry or extensive clinical trial experience

Contract Medical Monitor

• Part-time/ad hoc - needed about 4-5 hrs/week or 20-25 hrs/month
• Fully RemoteDuties are full-scale Medical Monitor - SAE narratives; trends, data analysis, consulting with PI about patients cases
• for a NASH study
• US Medical degree -; but will accept foreign MD if have true US Med Monitor experience
• Need experience NASH specifically

Job Description/Job Duties:

• Review safety reports generated by COMPANY data management team (e.g., adverse events by highest severity and relationship, laboratory and vital signs data integration with adverse events)
• Responsible for ongoing monitoring of reports of adverse events/SAEs submitted by the clinical sites to ensure good clinical practice and to identify safety concerns quickly. The SAE evaluations by the medical monitor are usually blinded to treatment assignment.
• Provide Medical review of study level data and participate in an editorial capacity in the development, review and finalization of study narrative summaries, Clinical Study Reports and publications in conjunction with Medical Writing Group.
• Provide Medical review of study level data and participate in an editorial capacity in the development, review and finalization of study narrative summaries, Clinical Study Reports and publications in conjunction with Medical Writing Group.
• Knowledge of ICH/GCP/FDA regulations and guidelines
• At least 3 years drug development experience in Pharma, Biotech, CRO industry or extensive clinical trial experience