Manager, Clinical Documentation Center Operations

Lake County, IL, US
Oct 03, 2018
Required Education
Bachelors Degree
Position Type
Full time
Functional leadership in CDC by providing tactical planning and oversight of VAULT eTMF and other systems, to include being the liaison with other functional areas.
Project Manager of business process efficiencies and improvements related to VAULT eTMF and other systems, to include implementation and user acceptance/knowledge management.
SME for all CDC processes, including work instructions.
May conduct training and participate in mentoring junior staff.

Key Responsibilities Includes :

  • Manages day-to-day eTMF system utilization by:
    -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.
  • Complies with GCP, AbbVie SOPs and functional area processes.
  • 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

Equal Opportunity Employer Minorities/Women/Veterans/Disabled