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Job description
Company Description
About AbbVie
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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.
Job Description
AbbVie Clinical Data Strategy and Operations is the best-in-class team within its cross-industry peer group and is responsible for bringing people, process, and technology together to generate business value from clinical trials data. Our operational model is exemplified through execution and innovation. This role is key to ensuring successful delivery against the program- and study-level accountabilities assigned to Clinical Data Strategy and Operations (CDSO).
Responsibilities
Aligns CDSOstudy teams with program- and study-level strategies. For assigned studies, leads the CDSOStudy Team and represents DS as a member of the cross-functional study team
For assigned studies, acts as single point of contact and accountable operational lead from DSS. Coordinates associated DSS study teams to meet operational objectives. Engages and connects global functional and cross-functional teams
Interacts with and influences cross-functional team members to achieve program and study objectives
Utilizes operational analytics and project management tools to optimize execution of programs and studies, to manage internal and external resources, to track study progress, and to prepare study status reports. Anticipates and identifies issues that could affect timelines or quality and develops options and solutions
Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and to functional quality standards. Stays abreast of new and/or evolving local regulations, guidelines and policies related to clinical development
Participates in oversight of vendors and provides feedback related to study operations, issues, and trends in performance
Responsible for coaching and mentoring Data Science Associates. May include indirect supervision of work for contract resources
Participates in CDSOand cross-functional innovation and process improvement initiatives
Contributes to study execution “lessons learned” across functions
Qualifications
Bachelor’s degree in business, management information systems, computer science, life sciences or equivalent. Master’s preferred. PMP Certification or Lean Six Sigma Green Belt desired
Must have at 3+ years of pharma / clinical research / data management / health care experience or 5+ years of project management experience (and / or applicable work experience)
Strong understanding of clinical trial process and clinical technology. Experience in managing a clinical trial from initiation through to completion is preferred
Demonstrated effective leadership skills
Demonstrated ability to influence others without direct authority
Demonstrated effective communication skills
Demonstrated effective analytical skills
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:
The compensation range described below is the range of possible base pay compensation that the Company believes ingood faith it will pay for this role at the time of this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographiclocation,andwemayultimatelypaymore or less than the posted range.This range may bemodifiedin thefuture.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
This job is eligible toparticipatein our short-term incentiveprograms.
Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.Theamountandavailabilityof anybonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company'ssoleandabsolutediscretion unless and until paid andmay bemodifiedat the Company’s sole and absolute discretion, consistent withapplicable 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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Worksite address
irvine, CA, 92713, US
Who can apply
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