Associate Clinical Research Manager (aCRM) - Lung

Job Description With support of other CRMs and/or TA-Head/CRD, this role is accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, policies and procedures, quality standards and adverse event reporting requirements internally and externally. The associate CRM could be responsible for a particular study for a country or a cluster. Responsibilities include, but are not limited to : Main Point of Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT). Responsible for project management of the assigned studies: pro-actively plans, drives and tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and close out. Accountable for performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, our company policies and procedures, quality standards and adverse event reporting requirements internally and externally. Reviews Monitoring Visits Reports and escalates performance issues and training needs to CRA-Manager and/or functional vendor and internal management as needed. Performs Quality control visits as required. Leads local study teams to high performance: trains in the protocol other local roles, closely collaborates with and supports CRAs as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration (including the CTCs, CRAs and COMs). Responsible for creating and executing a local risk management plan for assigned studies. Ensures compliance with CTMS, eTMF and other key systems in assigned studies. Escalates as needed different challenges and issues to TA-Head/CRD/CCQM and or CTT (as appropriate). Identifies and shares best practices. Responsible for collaboration with functional outsourcing vendors, investigators, other external par