Business Specialist, Clinical Documentation Center

Employer
AbbVie
Location
Lake County, IL, US
Posted
Aug 21, 2019
Ref
1905624
Required Education
Associate Degree
Position Type
Full time
Performs key operational activities across the Clinical Documentation Center for master files through life cycle. Collaborates with Master File Owners to support inspection readiness of clinical documentation / master files; may be aligned by Therapeutic Area but expected to work across all areas of the organization.

Responsibilities

• Applies critical thinking to ensure real-time inspection readiness of clinical documentation by:

- investigates and proactively resolved issues
- runs and performs review of reports and dashboards within eTMF
- produces eTMF metrics
- communicates to Master File owner(s) "root cause" analysis and potential data integrity concerns
  • Leads to completion of the final reconciliation/review and archival of individual master files, working closely with the Clinical Documentation Associate (CDA), CDC leadership and other TMF stakeholders (i.e., CPD, SM&M, DSS, BSO).
  • For CRO managed study TMFs: conduct QC of artifacts (may also include uploading and classifying); involvement with transfer of CRO TMFs into AbbVie eTMF system
  • Provides audit and inspection preparation support for paper and electronic TMFs, to include, but not limited to (on selected master files):
    - conduct data integrity checks
    - run & analyze reports for TMF completeness
    - work with the assigned CDA to follow-up on outstanding items with other functional areas
    - contribute to completion of pre-inspection requests
  • During an inspection:
    - function at the subject matter expert of the eTMF system navigation, including being present in the "front room" with the Auditors/Inspectors
    - participate in responding to auditor/inspector requests (may be required to put the response together)
  • Conduct TMF conversion activities; involvement with the transfer of TMFs from external entities (i.e., CRO, other pharmaceutical companies).
  • Provides suggestions for CDC work instructions/job aides and contributes to functional area continuous improvement projects and/or work streams.
  • Complies with GCP, AbbVie SOPs and functional area processes.


Basic:

  • High school diploma or equivalent; Bachelor degree or international equivalent is preferred.
  • With at least 4 years of professional work experience.
  • Demonstrates analytical, critical thinking and organizational skills.
  • Ability to independently perform multiple tasks at the same time.
  • Good communication skills (oral and written)
  • Proven effective, collaborative interactions with colleagues
  • Experience working in electronic systems

Key Stakeholders

Members of Clinical Documentation Center; Colleagues in Development and Global Medical Affairs responsible for contributing/owning master file artifacts.

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.