“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.

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.

Qualifications

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:

The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this roleat the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on manyfactors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
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.

Note: No amount of pay is considered to be wages or compensation until such amount isearned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that areallocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolutediscretion, consistent with applicable law.

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.

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