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 www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Job Description
Purpose:
The Clinical Data Strategy and Operations (CDSO) Data Strategy Lead serves as the study start-up domain expert and key strategic partner to the clinical study team, owning all data-related study start-up deliverables from protocol development through system design and go-live. The role leads cross-functional collaboration to ensure data strategies, standards, and technologies are consistently embedded into clinical plans, while translating complex data and technology concepts into actionable decisions for the study team. Through strong project management, risk oversight, and continuous process optimization, the Data Strategy Lead is key to ensuring successful clinical trial technology delivery.
Responsibilities:
Serves as the CDSO study start-up subject matter expert and single point of contact for assigned studies, owning all data-related start-up deliverables from protocol development through system go-live.
Leads data management study start-up end-to-end, partnering both within CDSO and across the study team to enable on-time study start. Leverages operational analytics and project management tools to optimize execution, track progress, and escalate and resolve issues affecting timelines or quality.
Ensures consistency in data strategy, standards, CRFs, and surveillance approaches across studies and therapeutic area(s). Translates complex data, technology, and standards concepts into clear, decision-ready guidance for study teams.
Drives the pull-through of critical-to-quality factors and data criticality assessments, ensuring they are translated and implemented into downstream data systems.
Ensures adherence to federal and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie SOPs, and functional quality standards; stays abreast of evolving guidance.
Influences without direct authority, using data and evidence to drive aligned, mutually beneficial outcomes for AbbVie.
Leads CDSO innovation and process improvement initiatives and participates in cross-functional initiatives.
Responsible for coaching and mentoring team members.
This role is a hybrid role with 3 days a week onsite.
Qualifications
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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.
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Must have 6+ years of pharma / clinical research / data management / health care experience or 8+ years of project management experience (and / or applicable work experience).
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In-depth understanding of clinical trial processes and clinical technology. Management of a clinical trial from initiation through to completion in a lead role is preferred
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Demonstrated performance as a functional leader
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Demonstrated ability to influence others without direct authority
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Demonstrated ability to successfully coach / mentor in a matrix environment
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Demonstrated effective communication skills
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Demonstrated effective analytical skills
Additional Information
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 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 long-term incentive programs.
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:
https://www.abbvie.com/join-us/reasonable-accommodations.html
