Senior Clinical Trial Manager

CSL is seeking a Senior Clinical Trial Case Manager to lead end-to-end case management for global biotechnology and pharmaceutical studies. In this role, you will oversee case processing, data review, and safety documentation, ensuring accuracy, patient safety, and adherence to ICH-GCP and global regulatory standards. You will collaborate closely with investigators, CROs, and internal teams, drive inspection readiness, and mentor junior staff. At CSL, you’ll join a patient-focused, science-driven, and inclusive culture where your work directly supports life-saving therapies and global trial excellence. Lead end-to-end management of global clinical trial case activities for CSL studies Oversee case processing, data review, and safety documentation to ensure accuracy and timeliness Collaborate with investigators, CROs, and internal teams to resolve case-related issues Ensure compliance with GCP, ICH, FDA, and global regulatory requirements Develop and refine case management workflows, SOPs, and quality standards Monitor trial metrics and generate reports on case status and safety trends Support inspection readiness and respond to regulatory and audit queries Provide mentorship and guidance to junior case managers and trial staff Contribute clinical and operational input to study design and risk management plans Drive continuous improvement initiatives to enhance trial efficiency and patient safety Clinical trial management Case processing and safety data review GCP and ICH regulatory compliance Pharmacovigilance and safety reporting Clinical data management systems (EDC, CTMS, safety DB) Risk management and quality oversight Regulatory documentation and inspection readiness Cross-functional collaboration and stakeholder management SOP development and process improvement Oncology/rare disease therapeutic area knowledge Medical Insurance Dental Insurance Vision Insurance Life Insurance 401k RN, PharmD, MD, or other clinical credential preferred Certification in Clinical Research (e.g., ACRP, SOCRA) preferred Strong knowledge of ICH-GCP and global pharmacovigilance regulations