Manager, Data Standards

AbbVie Inc; North Chicago (IL); Remote; USD 90,000 - 130,000; Full time

Job summary

An established industry player is seeking a Manager for Clinical Data and Reporting Standards to lead the development of data standards for clinical trials. This remote role involves collaborating with cross-functional teams to define and implement standards, ensuring compliance with industry regulations, and mentoring junior staff. You will play a crucial role in enhancing data collection and reporting processes, making a significant impact on the quality of clinical research. Join a forward-thinking organization that values innovation and offers comprehensive benefits, including paid time off and 401(k) participation.

Benefits

Paid Time Off

Insurance

401(k)

Incentive Programs

Qualifications

• 8+ years of clinical research experience with a focus on data standards.
• Experience leading development of standards for data collection and reporting.

Responsibilities

• Participate in the development of data and reporting standards for clinical trials.
• Ensure conformance to CDISC standards and industry best practices.
• Mentor junior team members and drive process improvements.

Skills

SDTM

CDASH

ADaM

Clinical Research

Data Collection Standards

Regulatory Compliance

Education

Master's Degree in a relevant field

Bachelor's Degree in a relevant field

Job description

Company Description

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 TikTok.

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 ensures conformance to CDISC standards and industry best practices. 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 deploying next-generation processes and technology.

Standards Development responsibilities include:

1. Actively participating with a cross-functional team of subject matter experts to define standards such as:

• SDTM mapping
• Data Collection
• Data Review Rules

Participating in defining study-level and product-level standards, including:

• Tables, listings, or figures
• Safety analysis displays
• ADaM mapping and derivation

Ensuring standards are clearly defined with proper documentation of assumptions and decisions to support pipeline activities.

Ensuring consistency across standard types (e.g., eCRF standards with TLF standards, SDTM with ADaM).

Developing training materials on the proper use of standards.

Communicating ongoing standard development activities organization-wide.

Pipeline responsibilities include:

1. Creating, reviewing, and providing feedback on SDTM Mapping Specifications and Trial Design Domains.
2. Providing feedback on CRF design and SDTM datasets to support regulatory compliance.
3. Overseeing creation of SDTM define.xml, annotated CRF, and Clinical Study Data Reviewer’s Guides for submissions.
4. Consulting on conformance issues and working with study teams to resolve them.

Other responsibilities include:

1. Representing AbbVie's interests in industry standards development projects.
2. Staying current with industry standards and regulatory requirements.
3. Identifying and driving process and content improvements.
4. Mentoring junior team members.

Qualifications

This is a remote opportunity available anywhere in the US.

• Experience leading development of standards for data collection, tabulation, analysis, and reporting.
• Experience with SDTM is required.
• Experience with CDASH is highly recommended.
• Experience with ADaM, Analysis Results Metadata, or TLF standards is helpful.
• Active participation in CDISC teams is preferred.
• Experience with preparing SDTM datasets and documentation for regulatory submissions.

Education and experience requirements

• MS with 8 years of relevant clinical research experience, or
• BS with 10 years of relevant clinical research experience.

Additional Information

This role is eligible for pay disclosure requirements under applicable state or local law, with compensation ranges provided accordingly. We offer comprehensive benefits, including paid time off, insurance, 401(k), and participation in incentive programs. Compensation details are at the company's discretion and may vary based on location and other factors.

AbbVie is an equal opportunity employer committed to diversity and inclusion. For more information, visit this link. Applicants seeking accommodations can learn more at this link.