Senior Clinical Trial Case Manager

Overview

Acts as case management subject‑matter expert in cross‑functional teams for assigned clinical trials, managing case management activities to ensure compliance with national and international regulations, GxP guidelines, and company policies. Oversees the delivery of Safety Reporting Plans, identifies and monitors KPIs/KQIs, and supports preparation and conduct of PV and GxP inspections and audits. Maintains clinical trial case management documentation, ensures vendor compliance with GSPV standards for SAE, AESI, and pregnancy reports, and serves as the primary contact for all GSPV PV operations queries.

Provides training to vendors and GSPV team members, participates in database enhancements, and develops and implements pharmacovigilance procedures to ensure timely processing and analysis of safety data. Leads or oversees ICSR reporting compliance analyses, liaises internally and externally to meet regulatory reporting requirements, and prepares Suspected Unexpected Serious Adverse Reactions for regulatory submission. May drive or contribute to cross‑functional projects to fulfill GxP requirements and improve inspection readiness.

• Manage case management activities for assigned clinical studies, ensuring compliance with national and international regulations, GxP guidelines, and company policies.
• Deliver Safety Reporting Plans, identify, implement, and monitor KPIs/KQIs across clinical case management activities.
• Support preparation and conduct of PV and other GxP inspections and audits as required.
• Establish, maintain, and ensure the maintenance of clinical trial case management documents, such as safety reporting plans and reporting responsibilities, in line with regulations and internal standards.
• Oversee vendors to ensure GSPV standards are maintained for processing of SAE, AESI, and pregnancy cases, and compliance with expedited reporting requirements.
• Act as the primary contact for external vendors handling all GSPV PV operations queries related to assigned clinical trials.
• Prepare and provide study‑specific training to external vendors and GSPV team members involved in the clinical trial.
• Participate in drug safety database enhancements and upgrades by providing input from a clinical trial perspective.
• Develop, implement, and oversee pharmacovigilance procedures and processes to ensure uniform and timely processing and analysis of safety data.
• Ensure correct coding of all event and drug terms and maintain inter‑ and intra‑consistency for case evaluations.
• Lead or oversee ICSR reporting compliance analyses provided by vendors and associated CAPAs from clinical trial case management.
• Act as a liaison internally and with external collaborators to develop processes that meet regulatory reporting requirements.
• Oversee preparation of Suspected Unexpected Serious Adverse Reactions for submission to external regulatory agencies.
• Lead or contribute to cross‑functional projects aimed at fulfilling GxP requirements and improving inspection readiness.

• Bachelor's degree or equivalent in a life science discipline (e.g., nursing, biological sciences, pharmaceutical sciences, or Medical Documentation).
• Master's or PhD in Life Sciences is preferred.
• 7+ years of pharmacovigilance experience in a multinational pharmaceutical environment.
• Expert knowledge of local and international regulations and PV processes.
• Knowledge of local and international GxP regulations, IT standards, privacy protection requirements, and other relevant legislation.
• Experience with regulatory inspections.
• Experience administering complex data sets.
• Experience managing CAPA and SOP development projects.
• Experience with relevant software applications.
• Experience working within a GxP‑regulated environment.

Equal Opportunity

Employer:

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit