Operations & Business Analyst II, Clinical Documentation Center Operation

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.

The Systems Operations Analyst is a subject matter expert in the Vault Clinical system and its processes. They excel in cross-functional collaboration, translating business needs into impactful system functionality enhancements, empowering study teams and guiding Leadership with strategic support.

Ensures Master File Owners and Document Owners (i.e. functional areas) have the knowledge and tools to ensure inspection readiness of clinical documentation/master files. Subject Matter Expert for VAULT Clinical system and processes.

• Functional Area Subject Matter Expert for system-related activities, to include but not limited to:
  - provide answers to stakeholder system-related questions
  - consider and take action on stakeholder requests & suggestions
  - review queries/issues, identify trends, investigate potential root cause(s) and execute on solutions
  - Lead stakeholder SME and cross-functional meetings
  - Business level maintenance of Vault Clinical system
• Works closely with IT and other stakeholders on system integrations with VAULT Clinical system
• Provides audit and inspection preparation support for eTMFs; involvement with inspections/inspector interviews
  - Function at the subject matter expert of the eTMF system navigation, may include being present in the front room, with the Auditors/Inspectors
  - Participate in responding to auditors/inspector requests (may be required to put the response together)
• Conducts quality control checks across the Vault Clinical system, including but not limited to CRO studies
• Creates, runs and interprets reports and dashboards within Vault Clinical; produces Vault Clinical metrics
• Contributes to and executes on strategic training plan; creates and conducts training across Vault Clinical stakeholders
• Operates independently, leads and mentors as a Subject Matter Expert
• Provide input and/or recommendations to SOPs, Work Instructions and Job Aides related to Vault Clinical processes on a regular basis. Proactively identifies areas for process improvement; lead functional area continuous improvement projects and suggest solutions to mitigate deficiencies/enhance processes; may participate in cross-functional initiatives
• Works closely with Clinical Documentation Center (CDC) colleagues, document owners (i.e. functional areas), and IT (BSOS) , including but not limited to
  - final reconciliation of archival master files
  - Investigational Product Release
• Complies with GCP, AbbVie SOPs and functional area processes

• Bachelor's degree required with min. 5 years relevant industry experience in clinical document management or equivalent experience
• Strong communication and presentation skills (oral and written).
• Proven analytical, critical thinking and organizational skills.
• Demonstrates ability to effectively interact with colleagues in a cross-functional environment.
• Proficient  in application of clinical documentation business procedures.
• Proficient in use of electronic systems.
• Operates independently with the ability to manage multiple larger projects at the same time.

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​​

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• 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 role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors 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. ​​

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Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable 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 absolute discretion, 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. 

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:

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