Sr Manager, Case Mgmt, Clinical Trial Safety

What You'll Do Overall case management activities for clinical trial ICSRs Author and maintain the SMP Perform data entry and in-line QC as well as retrospective QC Liaise with ICSR Medical Evaluation team to solicit quality feedback and implement improvements Oversee case workflow Review and resolution of clinical/safety database reconciliation Oversee clinical trial queries to sites/Investigators, escalating as required Manage late case investigations for late regulatory reporting Manage translations of source documents via vendor Collaborate with TMF Operations and Clinical Safety Operations Management of unblind accounts for CT ICSR SUSAR reporting Who You Are You are a seasoned case processor with a passion for quality and compliance.

You have successfully managed case processing teams with high quality ICSRs and on time regulatory submissions. You are agile and decisive and will take initiative to use data to drive proposals for process improvements or quality initiatives.

Required Skills BS degree in science or healthcare 7+ years of relevant PV experience, including clinical trial experience Direct line management and/or case processing team management Knowledge of global and local safety regulations Excellent written and verbal communication skills Excellent project management skills Must be effective and collaborative in a fast-paced and matrixed environment Effective managerial skills Strong decision making skills Job Level: Management Additional Information The base compensation range for this role is: $141,000.00-$188,000.00 Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.