AbbVie Senior Manager, (CDC) Clinical Documentation Center in Lake County, Illinois
Senior Manager, (CDC) Clinical Documentation Center
USA, Illinois, Lake County
Research & Development
Leads teams to ensure Trial Master File (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
AbbVie is an Equal Employment Opportunity employer: At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.
Significant Work Activities and Conditions: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel: Yes, 5 % of the Time
Job Type: Experienced