• The Manager, Safety Data Collection, Clinical Trials is responsible for managing the Pharmacovigilance (PV) operations of Pre and Post-approval Clinical Studies globally. The employee supports the Senior Manager, Safety Data Collection, Clinical Trials and is responsible for setting the safety operations strategy, establishing the safety report collection standards and processes, and ensuring they are implemented and executed consistently throughout all Pre and Post-Marketing Clinical Studies globally. The AE Intake Clinical Trials Associate will provide partner / vendor oversight in relation to Clinical Trial safety report collection and will collaborate with other functions (e.g., Clinical Operations, Medical Affairs, Data Management, Medical Writing, Regulatory, Biostatistics, and others ) to ensure consistency with regulations and with departmental goals and objectives. Where relevant, when partners (e.g. Quintiles Strategic Partnership) have additional safety related responsibilities, the manager ensures proper coordination between the partner and the SABR Subject Matter Expert/function lead
• Support Senior Manager, Safety Data Collection, Clinical Trials with setting the safety operation strategy and establishing the safety report collection standards and processes for Pre and Post-approval Clinical Studies globally Senior Manager, Safety Data Collection, Clinical Trials 20%
• Execute the development, maintenance and implementation of Controlled documents (SOPs), data handling conventions and other process documents for Clinical Trials and Post-Marketing Clinical Studies
• Safety operational content and processes for Clinical Trial and Post-Marketing Clinical Study tools for report collection such as protocols, CRFs, SAE forms, Pregnancy forms
• Tools and processes for database requirements and configurations to enable safety-related activities during studies
• Training requirements and materials for Clinical Trial safety report collection
• Report metrics and KPIs for Clinical Trial safety report collection Senior Manager, Safety Data Collection, Clinical Trials 20%
• Oversee and ensure study safety operational requirements are operationalized Senior Manager, Safety Data Collection, Clinical Trials 15%
• Support the following Strategic Partner / vendor oversight activities, in conjunction with relevant functions (such as Global Clinical Operations) in relation to Clinical Trial safety report collection:
• Provide functional support / input to set up partner and vendor relationship (e.g., business requirements, vendor selection, contract details, vendor oversight / safety management plans)
• Support onboarding and ongoing maintenance of partner and vendor status to perform work (e.g., access, training, technology set-up)
• Provide ongoing support of partners and vendors (e.g., questions, issues, meetings)
• Conduct partner oversight and performance management on contracted work (e.g., monitoring reports, quality evaluations, annual meetings) Senior Manager, Safety Data Collection, Clinical Trials 20%
• Communicates on PV legislation and regulatory commitments across the organization and externally Senior Manager, Safety Data Collection, Clinical Trials 5%
• Acts as subject matter expert on Pharmacovigilance (PV) operations of Pre and Post-Marketing Clinical Studies during audits / inspections Senior Manager, Safety Data Collection, Clinical Trials 10%