The Clinical Trial Submission Manager (CT-SM) is accountable for working with contributing business lines to lead submissions execution timelines for designated CTAs. They may operate as regulatory Subject Matter Expert for a CTA and drive submission teams towards the timely delivery of globally compliant submission-ready components. The CT-SM is required to author & deliver customized documentation for selected submissions across multiple markets, which may include Radiology form, Bio-bank Submissions & IVDR compliant content.

• Drives Regional submission management activities for their assigned protocols. Partners with global Submission and Portfolio Manager, GSSO lines and/or third-party partners, with responsibility for representation and management of required regulatory and Central Ethics activities, standards and deliverables associated with CTA submission development and execution for designated assets and/or geographies.
• Support and leads Regional and global efforts to ensure high quality components and submissions that are compliant with industry, agency and format guidelines, regulatory strategies, policies, and timelines.
• Liaises with GSSO, regarding essential documents that cross both HA and EC submission and translation processes driving compliance and timely delivery,
• Prepare, review and submit submissions to HA/Regional CTA, in order to obtain all necessary authorizations/approvals pertaining to the clinical trial conduct.
• Responsible for the co-ordination of translations for local documents required for submission.
• Manages the compilation for submission build, contributing to CTA & CE approvals and authoring documentation as required.
• Acts as Subject Matter Expert for CTRSE and provides country-level intelligence on clinical trial regulatory (CTR). Ensures that local country regulatory intelligence, as it pertains to the activities of the CTR team, is maintained on the central repository, e.g. Competent Authority submission requirements.
• Coordinates submission production and assists with definition, development, and implementation of regional submissions policies and technologies to meet evolving business needs.
• Escalates, informs and resolves any issues that may impact submission builds or the logistics of global submission delivery to regional and local partners or Health Authorities.
• Serves as a major source of innovative ideas seeking and developing efficiencies and effectiveness within the process by collaboration with key customer and supplier groups and business partners.
• Promotes professional development through mentoring and motivating colleagues.
• Promotes the use of Document Management and Archival systems and standard document authoring, partnering with supplier groups as necessary in order to produce timely delivery of submission/archive ready components.
• Functions as a change agent that can exhibit regulatory knowledge and awareness, technical competence, sound judgment, and a professional demeanor.
• Operates as a single BU Liaison point of contact for Regional Regulatory Leads and designated CTAs.
• Leads the interpretation of dossier requirements to produce business processes and ensure that those processes are implemented where appropriate at global and local level.
• Manages own time to meet objectives; forecasts and plans projects across multiple markets
• Provides guidance to and leads CTA submissions and process improvement projects, making decisions independently.
• Considered a technical resource within the group.