Clinical Document Management Learning Manager
Core
Design and deliver learning programs to improve Trial Master File (TMF) health and adoption of Clinical Document Management (CDGM) standards across Novartis.
Role type
Learning Manager specializing in Clinical Document Management and TMF compliance
Builds
Learning and capability programs for TMF and CDGM services
Domain
Pharmaceutical clinical research and regulatory compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical research experience, clinical documentation/records management, cross-functional project planning, metrics and KPI development, subject matter expertise in TMF processes, audit and inspection readiness support, knowledge management framework creation
Preferred skills
None stated
Technologies
None stated
Responsibilities
Design and deliver effective learning and capability programs for TMF and CDGM services; Partner cross-functionally to identify learning needs and implement tailored knowledge solutions; Develop and manage metrics, dashboards, and key performance indicators to track learning effectiveness; Collaborate with internal teams and external partners to align on CDGM learning and capability requirements; Serve as subject matter expert on TMF learning processes, tools, and capability development practices; Drive initiatives to improve TMF health and strengthen adoption of documentation standards; Support audit and inspection readiness, including root cause analysis and corrective and preventive actions; Partner with enterprise learning and knowledge groups to align with best practices and innovations; Act as CDGM point of contact for projects, ensuring engagement and integration with business initiatives; Create and manage knowledge management frameworks to support continuous learning and process improvement
Seniority
Mid-level, hands-on IC