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Independent Drug Monitoring, Manager

IQVIA · Parsippany, New Jersey, US

Role Overview: The role will be responsible for independent drug monitoring for assigned studies. This responsibility will include end to end ownership for t...

Job description

Role Overview: The role will be responsible for independent drug monitoring for assigned studies. This responsibility will include end to end ownership for the trial, from the initial set up and drug blinding activities, to ongoing monitoring of studies, and any duties needed for the successful closure of said trials. This role will escalate any issues found during monitoring and will work to resolve said issues. This role will be responsible for keeping the study team, sites, and all other applicable stakeholders well informed of the progress of drug monitoring as well as communicating any compliance issues. Further duties include developing documents and materials included monitoring visit reports, process documents, and training materials for junior staff. Responsibilities: escalation of major/critical issues in a blinded manner; follow up appropriately to closure. manner. addressed at sites. Act as primary point of contact for the IDMs. protocol amendments, changes in timelines, etc and monitoring plans. queries, if applicable. stakeholders. readiness. Qualifications: scientific or business discipline. when limited information is available. IQVIA is a leading global provider of...