AbbVie Manager of Clinical Documentation Center Operations providing tactical planning and oversight of VAULT eTMF systems. Leads process improvements, training, and audit readiness activities.
Responsibilities
Managing the implementation of VAULT eTMF system enhancements across the business
Managing initial and ongoing training/coaching on system functionality and processes to all internal and external VAULT eTMF users
Works collaboratively with study support colleagues to coordinate audit and inspection readiness activities related to eTMF
Works collaboratively with study support colleagues to ensure quality checks are being conducted on the eTMF
Project Manager for the planning and execution of eTMF transfers to/from external partners.
Participates in the review of and assessment of metrics/ dashboards.
Evaluates and updates work instructions related to department processes.
Project manages the process of evaluating and updating the artifact maps/Expected Document Lists.
Comply with GCP, AbbVie SOPs and functional area processes.
Qualification
Proven communicationDemonstrates problem solving skills
Required
Reports to an Assistant/Associate Director and will have direct reports.
Bachelor degree or international equivalent is required, degree related to IT/Systems preferred
With at least 6 years Pharma experience or related professional experience.
Demonstration of successful coaching/mentoring in a matrix environment.
Proven communication, organizational, project management and leadership skills.
Demonstrates problem solving skills
Competent utilization of electronic systems
Possesses a high level of core and technical competencies related to development, product, and trial master file maintenance and processes
Proven successful coaching/mentoring in a matrix environment
