Jobs in the United States

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Senior Registered Client Service Associate (Denver, CO)
Raymond James & Associates, Inc.
Denver, CO
…Raymond James is seeking a dynamic Registered Client Service Associate who is a motivated, detail oriented and creative problem solver to join our growing team. This essential role helps to…
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Registered Client Service Associate (Frisco, TX)
Raymond James & Associates, Inc.
Frisco, TX
…Raymond James is seeking a dynamic Registered Client Service Associate who is a motivated, detail oriented and creative problem solver to join our growing team. This essential role helps to…
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Asset & Wealth Management Operations - Alternative Private Operations - Dallas - Associate
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Senior Associate, Slate Product Marketing Strategy
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Early Careers Recruiter, Associate
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C
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Danville, IL
- $19 to $21.5 USD / hour
Associate's degree or Bachelor's degree in Business, Insurance, Risk Management, Finance, or a related field preferred.
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Specialist, EHS
AAR Corp
Rockford, IL
- $23.47 to $28.83 USD / hour
Associate's in Occupational Health and Safety or Environmental Health and Safety
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System Engineer I - Application Hosting
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o Associate’s degree and an additional two (2) years’ applicable technical experience OR
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Front Office Assistant
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VIENNA, WV
- $16 USD / hour
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Clinical Informatics Specialist
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Associate’s degree in an IT related field, business, informatics, a clinical field or equivalent and 7 years’ work related experience in the information technology field supporting…
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Senior .NET Application Developer - Enterprise Systems
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- $95,000 to $135,000 USD / year
Application Developer - Grant Management System Remediation & Workday Integration
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Associate Program Manager / Construction Manager
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New York, NY
GFT is seeking an Associate Program Manager / Construction Manager to join our Construction Services Team in New York, NY to work on construction projects. This role requiring regular…
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Registered Nurse Staff-Surgical-Night Shift
Southern Illinois Hospital Services Inc.
United States
Associate, Diploma, Bachelor’s degree or Master’s in Nursing
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Registered Nurse-Progressive Care Unit-Night Shift
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Registered Nurse - Stepdown Intensive Care Unit-Night Shift
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Learning Specialist
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Creve Coeur, MO · Lake Mary, FL
…determine opportunities for review and retraining needs that may be associate…
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Warehouse Supervisor – 1st Shift
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Nashville, TN
This role supports the Warehouse Day Shift Manager in overseeing all day shift operations · Supervises the operational flow of all day shift activities by working directly with Area Lead
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Retail Brand Experience Key Holder-NORTH PLAINS MALL
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We believe great associate experiences create great consumer experiences. When our associates feel supported, inspired and empowered, consumers feel it. Whether you're starting your career…
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Retail Sales Supervisor
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Cross-train in all areas of store operations including Stocking/Sales associate duties, and responsibilities
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Postdoc Research Associate
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Operations Support Specialist 2/3 (IPO Metrics and Data Analysis)
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In addition to the Level 2 requirements, the Level 3 candidate must have:
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MED LAB TECH-UHR LAB
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Bachelor’s or Associate degree in a chemical, physical, biological, or clinical laboratory science or medical technology from an accredited institution
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Staff Actuary
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Associate of the Society of Actuaries (ASA) and Membership in the American Academy of Actuaries (MAAA).
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Channel Development, Lead Retention
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…retention initiatives, and continuous performance optimization, the Associate Director is accountable for improving refill rates, increasing auto-refill adoption, reducing member attrition,…
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Sales Rotational Development Associate
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This position will be hybrid (Monday-Thursday in office) and based out of our One Atlantic Center (midtown Atlanta) office location · Ability to work in our Midtown Atlanta office on a hybrid schedule (Monday-Thursday in office)

AbbVie

Manager, Clinical Data & Reporting Standards - SDTM Programming (Hybrid)

Irvine, CA, United States

$109,500 to $208,500 USD / year

Apply on jobs.smartrecruiters.com About employer

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Job details

Pay: $109,500 to $208,500 USD / year
Posting language: English
Posted: Nov 13, 2026

Original 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 www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

The Manager, Clinical Data and Reporting Standards (CDARS) proactively participates in the development of data and reporting standards in support of AbbVie’s portfolio of clinical trials and ensuring AbbVie’s conformance to CDISC standards and industry best practices as well as pipeline based SDTM development. This role implements the strategy and framework for governance of standards as set by the Head and Associate Directors of CDARS and actively engages in deployment of next generation process and technology. Standards Development responsibilities include

Actively participating with a cross-functional team of subject matter experts to define one more of the following types of standards within the assigned therapeutic areas:
Data Collection
Data Review Rules
SDTM mapping
Participating in a cross-functional team of subject matter experts to define one more of the following types of standards within the assigned therapeutic areas:
ADaM mapping and derivation
Study-level tables, listings, or figures
Product-level safety analysis displays
Ensuring each standard is clearly defined, with appropriate documentation of relevant assumptions and decisions related to its use to support pipeline activities
Ensuring consistency across standard types (e.g. eCRF standards align with TLF standards, SDTM standards align with ADaM standards, etc.)
Develop training materials to the organization on the proper use of standards in pipeline activities
Communicate ongoing standard development activities across the organization

Pipeline responsibilities include

Providing feedback on CRF design and SDTM datasets to ensure data are collected and represented in a manner that support regulatory requirements to comply with CDISC standards (CDASH, SDTM and ADaM) and AbbVie standard extensions to CDISC
Review and provide feedback on SDTM Trial Design Domains
SDTM Programming based on SDTM specifications
Oversee the creation of SDTM datasets, define.xml, annotated CRF and Clinical Study Data Reviewer’s Guides for both FDA and PMDA submissions
Consult on conformance issues for SDTM and/or ADaM and work with the study team to resolve the problem either by correcting the data or metadata, or by providing an appropriate explanation

Other responsibilities include:

representing AbbVie’s interests in industry standards development projects,
staying current with industry standards such as CDISC, and the regulatory requirements related to their use
identifying improvements to the processes and content of standards, and driving those improvements to completion

Qualifications

Minimum Qualifications:

MS with 8 years of relevant experience, OR
BS with 10 years of relevant experience
Experience with SDTM programming is required
Experience leading development of standards for data collection, tabulation, analysis and/or reporting
Experience with preparing SDTM and/or ADaM datasets and documentation for regulatory submissions

Preferred Experience:

Experience with CDASH is highly recommended
Experience with ADaM, Analysis Results Metadata, or TLF standards are helpful
Active participation in CDISC teams preferred

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

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Jobs in the United States