Sr. Clinical Documentation Manager

Lake County, IL, US
Sep 11, 2018
Required Education
Bachelors Degree
Position Type
Full time
Responsible for resource planning and allocation of functional resources.
Management and coordination of inspection readiness activities for all TMFs across AbbVie portfolio, including sign-posted artifacts.
Ensures staff and clinical documentation is compliant with ICH, GXP, OEC and AbbVie SOPs for assigned Therapeutic Area(s).
Builds highly effective teams by developing staff and ensuring appropriate work assignments across the Clinical Documentation Center for the good of the department and the staff.

Key Responsibilities Includes :

  • Assesses workload of Clinical Documentation Center staff within assigned TA and across entire organization working with other Sr. Mgrs; ensures trained resources are available to support demand within assigned TA(s).
  • Manages staff to ensure real-time inspection readiness of clinical documentation.
  • Ensures real-time inspection readiness of clinical documentation by ensuring review of assigned product file(s) for accuracy and completeness and reporting status to appropriate artifact owner(s).
  • Analyzes metrics and recommends appropriate action as necessary; may collaborate with CDC Operations to identify areas for improvement.
  • Provide oversight on development and implementation of enhancements/initiatives within CDC.
  • 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 in Science or Business preferred.
  • With at least 8 years Pharma experience or related professional experience (of which at least 2 years in clinical research)
  • At least 2 years people management experience.
  • Proven communication, organizational, project management and leadership skills.
  • 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 changes, as well as changes to process and procedures

Equal Opportunity Employer Minorities/Women/Veterans/Disabled