Clinical Documentation Associate III

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.
• Collaborate 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.
• Proactively identify areas for improvement; lead functional area continuous improvement projects and suggest solutions to mitigate deficiencies/enhance processes; may participate in cross-functional initiatives.
• Operates independently, leads and mentors as a Subject Matter Expert.
• Provide input and/or recommendations to SOPs, Work Instructions and Job Aides.
• Complies with GCP, AbbVie SOPs and functional area processes.

Requirements

• List required and preferred qualifications (up to 10). Include education, skills and experience.
• Bachelor's degree required with min. 5 years relevant industry experience in clinical document management or equivalent experience
• Proven analytical and critical thinking skills.
• Operates independently.
• Possesses good presentation and strong communication skills; proven ability to successfully facilitate cross-functional team meetings.
• Ability to manage multiple large projects at the same time.
• Proficient in application of clinical documentation business procedures.
• Proficient in working in clinical documentation system.
• Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our short-term incentive programs.
• AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
• US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
• US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
• https://www.abbvie.com/join-us/reasonable-accommodations.html

Benefits

Additional Information

"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). Contributes to functional area development by being a subject matter expert for CDC and TMF stakeholders.

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