Description

Remote

Roles and Responsibilities:

- eCRF Design - Able to critically review eCRF designs to ensure compatibility/conformance with CDASH/SDTM standards. Recognizes limitations in eCRF design and works with the study team to correct flaws proactively.

- SDTM Conformance Mapping - Create and Reviews SDTM conformance mapping specifications applying SDTM TAUG and Abbvie standard.

- CDISC Validation Tools - Executes validation tools e.g. Pinnacle 21 and collaborates with other functions to resolve identified issues. Ensure any unresolved issues are appropriately documented e.g. Clinical Study Data Reviewers Guides.

- Create and review Trail Design domains

- Clear understanding of End-to-end traceability from Data Collection to Data reporting.

- Metadata Repository - Responsible for managing libraries of CDISC-related metadata terminology and related standards within the metadata repository. Provides governance oversight to Data Standards Analyst and Sr Data Standards Analyst to ensure consistency in metadata.

- Standards Development - Assist in the development of data standards.

- Standards Governance - Provide guidance to study team members on the appropriate use of AbbVies standards. Consult on complex study-specific data collection and mapping to SDTM.

- Cross-functional Team Participation - Represents the Clinical Data Reporting Standards group to ensure industry and AbbVie standards are followed and understood.

- Communication - Clearly communicates an understanding of clinical data standards concepts clinical principles and regulatory guidance and acts in accordance with those principles. Effectively presents data standards concepts and logical arguments to statistical programmers statisticians data scientists clinical development and regulatory study team members. Able to diplomatically and persuasively represent the interests of the Data Standards group in cross-functional initiatives.

Additional Skills & Qualifications

Qualifications:

- MS with 8 years of relevant clinical research experience or BS with 12 years relevant experience.

- Expert level of knowledge of CDASH SDTM define.xml and controlled terminology.

- Experience in mapping and converting legacy data into SDTM domains for eCTD submissions. Minimum of two successful submissions of CDISC compliant data.

- Knowledge of international regulations requirements and guidance associated with clinical data standards and the preparation of data sets for regulatory submission.

- Experience with metadata repository technology and its application in clinical data standards processes and experience with data standards governance.

Job Type & Location

This is a Contract position based out of North Chicago, IL.

Pay and Benefits

The pay range for this position is $68.00 - $70.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully remote position.

Application Deadline

This position is anticipated to close on Feb 18, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.