Clinical Monitoring Oversight Manager - Contractor

Job description

Summary The Clinical Monitoring Oversight Manager - Contractor (CMOM) will provide oversight of study monitoring activities (blinded and/or unblinded) to ensure data quality and patient safety in accordance with ICH GCP guidelines, local regulations, and applicable SOPs. The Clinical Monitoring Oversight Manager will work with Study Management Teams (SMT) to support Study Planning and Execution with drafting, implementing, and review of monitoring related study plans, identifying monitoring performance issues , managing site quality matters, assessing data quality metrics , documenting potential risks, escalating appropriate risks a nd issues, and communicating necessary action plans with cross functional S tudy M anagement T eam . For blinded studies, the CMOM may act as the lead unblinded Clin ical Op eration s contact, supporting unblinded study processes and associated oversight of monitoring expectations, including but not limited to the investigational product (IP) handling and accountability, management of the IXRS/IRT system, management of protocol deviations and unblinded safety reports, and documentation associated with these activities. The Clinical Monitoring Oversight...