Clinical Study Associate II

Summary

Join AbbVie as a Master File Owner, responsible for managing and ensuring inspection readiness of clinical documentation and Trial Master Files (TMF). You will perform quality control, collaborate with team members, develop TMF structure documentation, and support audits/inspections. This role requires a Bachelor's degree and 2+ years of relevant experience in clinical document management. The position offers remote work opportunities within the US and a comprehensive benefits package including paid time off, medical/dental/vision insurance, and 401(k). AbbVie is committed to diversity and inclusion and offers short-term incentive programs.

Requirements

• Bachelor's degree required with min. 2 years relevant industry experience in clinical document management or equivalent experience
• Proven analytical and critical thinking skills
• Operate with limited oversight
• Good oral and written communication skills; ability to facilitate cross-functional team meetings
• Ability to manage several projects at the same time
• Competent knowledge of clinical documentation business procedures
• Ability to independently work in clinical documentation system

Responsibilities

• Ensure 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
• Collaborate with Artifact owners; hold study team members accountable for respective sections of the TMF, report status to study team members by providing regular status updates & facilitate / lead routine TMF meetings and document the discussion/decisions made in the TMF
• Develop and maintain study-specific TMF structure documentation (i.e., Expected Document List, excel trackers for paper/hybrid TMF)
• Provide support and prepare TMF(s) for audits/inspections
• Contribute to (may lead) functional area continuous improvement projects and/or work streams
• Provide input and/or recommendations to SOPs, Work Instructions and Job Aides
• Comply with GCP, AbbVie SOPs and function area processes

Preferred Qualifications

This is a remote opportunity candidates are able to work anywhere in the US

Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k)
• Short-term incentive programs