Senior Manager, Plain Language Trial Summaries

As a Senior Manager of Plain Language Trial Summaries (PLTS) your primary accountability will be to independently provide project management and execution to ensure quality PLTS postings are prepared, translated and disseminated to investigational sites in compliance with the EU Clinical Trial Regulations and the Novartis Position on Clinical Study Transparency across BioMedical Research, Global Drug Development, Global Medical Affairs and local affiliates.

Fully home based and part of a committed and focused team working across multiple Phases and therapy areas. Applications from those with a Study Lead (Clinical Trials), Clinical Study Report (CSR) development, Clinical Site Management, Patient Safety, Medical Writing or similar background would be welcome.

Key Responsibilities
•Manage multiple PLTS through the entire process ensuring timelines are maintained. PLTS process steps include gathering required documentation for vendor contract preparation, arranging and/or leading PLTS review meetings, reviewing PLTS documents, ensuring study lead and medical lead review of PLTS, coordinating PLTS content finalization, PLTS translation and distribution by vendors and archiving of key documents in the document management system. Responsible for coordination of communications between vendor and the clinical team.
• Interpret, discuss and ensure appropriate trial data from the CSR is accurately represented in the PLTS. Independently address and resolve questions received from the therapy areas and country representatives. Identify potential timeline, quality, or resource issues.
• Review and maintain the CDO PLTS book of work in the Clinical Disclosure Office (CDO) Analysis and Reporting Tool and ensure the PLTS request for proposal process is complete for submission to the vendors.
• Responsible for staying current with the global PLTS work practice & health authority regulations to ensure harmonization of Novartis transparency processes and standards. Identify barriers to alignment of processes and discuss within the PLTS CDO team an implementation plan.
• Independently coordinate and conduct routine client trainings within BioMedical Research, Global Drug Development, Global Medical Affairs and local affiliates to drive quality and compliance and organizational alignment to changing disclosure requirements.
• Independently represent Novartis to internal and external stakeholders. Develop and maintain effective working relationships with global and country multidisciplinary leaders, such as Study Leads, M.D.s, medical writers, statistical programmers, and vendor project management teams.
• Review updates to the PLTS work practice and other CDO SOPs and preparation for external inspections & internal audits.
• Participate in the assessment, preparation and review of monthly PLTS disclosure metrics.
• Apply a continuous improvement mind set ensuring best practices are shared continually driving to deliver the most productive processes.