Manager, Clinical Data and Reporting Standards — SDTM Programming

Job overview

The Manager, Clinical Data and Reporting Standards — SDTM Programming role is listed in Florham Park, NJ, and the posting identifies it as hybrid; compensation is not specified. At AbbVie, the role supports clinical trials and the company’s mission to deliver medicines and solutions for serious health issues. The manager develops and governs clinical data and reporting standards and supports pipeline SDTM programming and regulatory submissions. The role works across subject-matter teams to maintain consistent, documented standards, advise study teams on conformance, and improve processes and technology.

What you'll do

• Participate in developing data collection, data review, SDTM mapping, ADaM mapping and derivation, and reporting standards
• document assumptions and decisions
• ensure consistency across standards
• develop training materials and communicate standards work
• review CRF design, SDTM datasets, and trial design domains
• program SDTM datasets
• oversee submission documentation
• consult on conformance issues
• represent AbbVie in industry standards projects and drive improvements.

What we're looking for

Skills & competencies

clinical data standards

sdtm programming

clinical research

abbvie

florham park nj

clinical trials

cdisc

adam

regulatory submissions

data governance

standards development

hybrid

Work arrangement

• Weekend coverage required

Benefits & perks

• Paid time off, medical, dental and vision insurance, 401(k) for eligible employees, and eligibility to participate in long-term incentive programs.

Why this role

Requires an MS and eight years of relevant clinical research experience or a BS and ten years; SDTM experience and experience leading standards development and preparing regulatory submission datasets and documentation are required.

About the employer

AbbVie is hiring for this role. Industry: Pharmaceutical Preparation Manufacturing. Sector: 32.