Senior Manager, Clinical Documentation Center Operations

North Chicago, Illinois, USA
May 30, 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 engagement of other functional areas and management of day-to-day system execution/direction across all internal and external VAULT eTMF users.
Responsible for coordination of business process efficiencies and improvements related to VAULT eTMF and other systems, to include overseeing implementation of VAULT eTMF system enhancements on AbbVie business processes.
Provide leadership for inspections/audits; collaborate with external partners to transfer TMFs; deliver paper TMF conversion plans and ensure execution against the plan; may provide direction and scoping of projects delivered by CDC Operations Analysts.
Owner of all CDC departmental processes (i.e., SOPs, Work Instructions), metrics and quality compliance  

Key Responsibilities Include:

  • Leads teams to ensure TMFs are compliant with GCP and AbbVie SOPs, including TMFs for all R&D studies and TMFs transferred to AbbVie through merger and/or acquisition.
  • Liaises with internal/external partners regarding VAULT eTMF capabilities; implements and executes on engagement strategy plan for internal/external (e.g., CROs, Investigative Site Staff, IRBs/ECs) users related to VAULT eTMF and other clinical systems.
  • Ensures consistent approach to inspection/audit readiness within the department, ensures colleagues are trained on process to prepare and support inspections; maintains project plans and provides oversight for successful execution; as well as development and execution of TMF quality assessments.
  • Supports hiring, training and developing staff.
  • Manages staff to ensure real-time inspection readiness of clinical documentation.
  • Analyzes metrics and recommends appropriate action as necessary; collaborates with CDC Study Support to identify areas for improvement in metrics and/or processes; Identifies trends and escalates areas of concern.
  • Oversees the process of evaluating and updating the artifact maps/Expected Document Lists.
  • Reviews and evaluates VAULT eTMF system enhancements, improvement requests, etc. and provides recommendations CDC leadership. Provide oversight on development and implementation of enhancements/initiatives with VAULT eTMF.
  • Fosters and maintains a culture inclusive of process improvement, collaboration and development.
  • 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 7 years Pharma experience or related professional experience
  • At least 2 years of people management experience.
  • Proven communication, organizational, project management and leadership skills with the ability to lead the CDC organization within a global matrix environment
  • Skilled at problem solving at operational and tactical levels
  • Must analyze organizational needs and assist in the design, implementation and maintenance of flexible work teams, capable of meeting changing business and regulatory requirements
  • Ability to lead employees through organizational, process and procedural changes
Key Stakeholders

  • Members of Clinical Documentation Center; Colleagues in Development and Medical Affairs responsible for contributing/owning product/study artifacts; External Partners.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled