Senior Manager, Clinical Data Systems

Biopharma Careers; Irvine (CA); On-site; USD 140,000 - 190,000; Full time

Job summary

AbbVie’s Data Science team in Irvine, CA seeks a Senior Manager, Clinical Data Systems to lead design and delivery of data platforms for clinical trials. You will manage resources, vendor deliverables, and cross-functional initiatives across clinical operations and IT.

A strong background in SAS/SQL, CDASH/SDTM, and regulatory knowledge is required. This role prioritizes data quality, process improvement, and talent development in a fast-paced environment, with a focus on scalable solutions and

Qualifications

• Bachelor’s degree in MIS, computer science, life sciences or equivalent; Master’s preferred.
• Demonstrated SAS/SQL programming skills and knowledge of CDASH/SDTM standards.
• Experience in clinical trial processes and matrix leadership.

Responsibilities

• Manage multiple teams and resources, optimizing performance and cost.
• Oversee vendor deliverables and SDTM data quality.
• Provide strategic direction and coaching across the organization.
• Foster cross-functional initiatives and talent development.
• Ensure regulatory-compliant data processes and reporting.

Skills

Influence without authority

Leadership

Communication

Analytical skills

Education

Bachelor’s degree in MIS/CS/Life sciences

Master’s degree preferred

Tools

SAS

SQL

Job description

# Senior Manager, Clinical Data SystemsIrvine, CA Full-timeClinical Development ManagerNotify me about similar jobsView Full Job & Apply at AbbVieAbbVie is the source of truth for this posting and owns the application process. We surface normalized context and market comparison you won't find on the original listing.## About this opportunityCompany 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 DescriptionAbbVie Data Science is the best-in-class team within its cross-industry peer group and is responsible for bringing people, process, and technology together to generate business value from clinical trials data. Our operational model is exemplified through execution and innovation. This role is key to ensuring successful delivery against the program and maintaining best in industry resources.ResponsibilitiesManage multiple TAManage technology evaluations and implementations for performance improvement and cost reduction.Creates and sustains an environment that attracts, develops and retains strong talent.Practice continuous improvement of processes and technology usage.Acts as subject matter expert and process owner.Supervises and allocates internal and external resources within the Therapeutic Area.Ensure all performance assessment responsibilities are achieved for direct reports. Provide training and feedback, resolve personnel issues, and manage talent retention for assigned staff.Responsible for the performance management of staff; supporting team in building and maintaining a high performing team, recruitment, onboarding, resource assignment, and development opportunities for staff within responsibility.Manage cross functional initiatives.Provides strategic direction, advice and guidance to staff in relation to operations responsibilities and activities; promotes best practice; ensures objectives are successfully met.Oversee vendor deliverables and ensure SDTM deliverables meet established quality standards, submission requirements, and applicable regulatory expectationQualificationsBachelor’s degree in management information systems, computer science, life sciences or equivalent. Master’s preferred.Must have 8+ years of experience with clinical database design, data loading, and database modeling concepts or 9+ years of experience in a similar technical or clinical development environment.Demonstrated intermediate SAS and/or SQL programming skills and expert knowledge of database concepts.In-depth knowledge of CDASH and SDTM Standards In-depth understanding of clinical trial processesDemonstrated ability to influence others without direct authority. Demonstrated performance as a key contributor to initiatives and advancement of the organization. Demonstrated ability to successfully coach/mentor in a matrix environment Demonstrated effective communication skills Demonstrated effective analytical skillsAdditional InformationAbbVie 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.htmlUS & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:https://www.abbvie.com/join-us/reasonable-accommodations.html