Lead, manage and mentor Clinical Sciences respiratory projects and ensure timely delivery of all deliverables. The responsibilities of the company Medical Monitor may include but is not limited to the following: Contribute and/or provide review to key study related documents such as protocols, informed consents and amendments, eCRFs, SAP, MMP, SMP, and TLFs.
Review of CRO medical monitoring capabilities as part of study start up and RFP process including the CRO MM CVs, MMP, and investigator/site lists as part of the vendor selection process or final CRO determination.
Provide guidance on subject eligibility, deviations, and other medical, safety, or protocol related questions to CRO MM, site investigators, and CRO and Sponsor study team.
Review of blinded efficacy and safety data, listings, tables, deviations, and provide supportive review of blinded SAE or SUSAR related documents and address or elevate any data ...