Associate I, Clinical Documentation

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

“Master File Owner” responsible for managing and ensuring inspection readiness of clinical documentation / master files. CDC representative on study team(s) with ownership of the study Trial Master File (TMF).

Responsibilities

• Ensures real-time inspection readiness of clinical documentation / TMF by performing quality control (QC) of the TMF/artifacts to ensure completeness, document quality and timeliness of upload of artifacts to the TMF.
• Collaborates with Artifact owners, holds study team members accountable for respective sections of the TMF, reports status to study team members by providing regular status updates & facilitating/leading routine TMF "health" meetings and documents the discussion/decisions made in the TMF.
• Develops and maintains study-specific TMF structure documentation (i.e. Expected Document List, excel trackers for paper/hybrid TMF).
• Provides support and prepares TMF(s) for audits / inspections.
• Contributes to functional area continuous improvement projects and/or work streams.
• Complies with GCP, AbbVie SOPs and functional area processes.

Qualifications

Qualifications

List required and preferred qualifications (up to 10). Include education, skills and experience.

• Bachelor’s degree or equivalent experience required
• 1-2 years relevant industry experience in clinical document management or equivalent experience
• Demonstrates analytical and critical thinking skills.
• Good oral and written communication skills; ability to facilitate cross-functional team meetings.
• Ability to manage a few projects at the same time.
• Demonstrates awareness of clinical documentation business procedure