Job Description This role will be key to ensure strong monitoring in our clinical trials. Under the oversight of the CRD or Head of Site Management and Monitoring, the person is responsible to manage a team of 6-14 CRAs and to ensure excellent study and site performance with strict adherence to local regulations, company SOPs and ICH GCP. As line manager, the role is critical to continuously develop key talents by providing training, support, and mentoring to the CRAs and properly manage situations of low or non-performance. The role will work at the country level with other local stakeholders e.g. CRM to ensure alignment and development of the country capabilities. The role will collaborate with country PLMs to ensure alignment across all monitoring functions. The person contributes to HQ capacity/resource planning activities to ensure efficient allocation of resources and work. Responsibilities include, but are not limited to: • Work allocation, staff development, and performance appraisal. • Provides input for capacity planning, including reporting of current manpower and forecasting of CRA capacity and needs, to provide efficient use of resources. • Work with CRAs, PLMs, and other functions to ensure consistency of processes and protocol implementation across the country, to reduce variability and provide predictability. • Interacts with sites as needed to resolve site or CRA operational issues to meet commitments in a timely manner in coordination with the study CRM. • Attend local Investigator Meetings if requested. • Interface with GCTO partners on clinical trial execution. • Escalates site performance issues to CRM and Clinical Research Director CRD. • People and Resource Management: o Manage CRA – career development, performance reviews, etc., including addressing low performance situations, and taking appropriate actions. o Support and resolve escalation of issues from CRAs. o Liaise with local HR and finance functions as required. o Contribute to HQ capacity/resource planning activities to ensure efficient allocation of resources and work. Manage local conflicts between resource and work. o Provides training, support, and mentoring to the CRA to ensure continuous development. o Ensures CRA compliance with corporate policies, procedures, and quality standards. Experience Requirements: Required: • Minimum of 5 years´ experience within Clinical Research • Minimum of 3 years' experience as CRA monitoring clinical trials • Line management experience preferred or at the minimum team leader experience Educational Requirements: Required: • Bachelor's degree in Science Preferred: • Advanced degree, (e.g. BA/BS or higher) with a strong emphasis in science and/or biology #J-18808-Ljbffr