SeniorClinicalResearchManager

Senior Clinical Research Manager (Sr. CRM) is responsible to manage a CRA team and to ensure excellent cell therapy study performance at site level, complying with AZ Procedural Documents, international guidelines such as ICH and GCP as well asrelevant local regulations. As line manager of CRA, he/she is accountable for developing talents by providing continuously coaching, training, support and monitoring to CRA. Contributes to cell therapy study resource allocation to ensure efficient work of study delivery. Sr. CRM contributes to hospital strategic cooperation for business continuous.Sr. CRM is also responsible to manage junior/less experienced CRM if applicable. **Typical Accountabilities** • Lead, guide, evaluate and develop the team, to ensure the quality execution and delivery of the site monitoring in the cell therapy sites. Build up the team spirit and contribute to efficient cell therapy organisation by working closely with team leader. • Develop and enhance cell therapy specific training program to CRA. • Ensuring adequate resources allocation for the cell therapy studies assigned and manage resource conflicts. • Accountable for build and retain an efficient team by providing leadership and monitoring to team members. • Contribute to the quality improvement of the cell therapy study processes and other procedures. Oversight relevant system which maintained by CRA with high quality. Review of monitoring reports/follow up letters of CRA as per study monitoring and/or local clinical quality management plans. Perform necessary accompanied site visits for CRA. • Assist study team in forecasting cell therapy study timelines, resources, recruitment, study materials and drugs. Contribute to high quality feasibility work. Provide guidance to study team on major study commitments including resolving any key issues identified. • Contribute to development strategic cooperation of clinical investigator network and maintain good relationship with key sites as assigned.