Clinical Operations Manager, Regulatory
Current-Therapeutic Area lead for Gyn/Onc and Breast Oncology studies (Oversee COM deliverables for all studies within women's cancers and provide support)-CTMS Subject Matter Expert -Manage country deliverables, timelines and results for assigned protocols to meet country deliverables through study lifecycle with a focus on study start up-Coordinate and liase with Clinical Research Manager, Clinical Research Associates, Clinical Trial Coordinators, Finance and Legal to ensure country deliverables are met-Oversee Clinical Trial Coordinators on assigned studies-Manage informed consent negotiation on country and site level for assigned protocols-Execute and oversee clinical trial country and site level submissions and approvalsfor assigned studies-Engage with regulatory authorities and institutional review boards/ethics committees to obtain country and site level approvals-Collect, file and QC documents for eTMF and maintain inspection ready state