Senior Manager, Clinical Data Systems

Regulatory Toolkit; Irvine (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

AbbVie Data Science is the best-in-class team within its cross-industry peer group and is responsible for turning clinical trials data into business value through people, processes, and technology.

This role will manage multiple therapeutic area initiatives, oversee data loading, SDTM/CDASH standards, and coordinate internal and external resources to ensure timely, high-quality regulatory deliverables.

Qualifications

• Bachelor’s degree in MIS, CS, life sciences or equivalent.
• 8+ years in clinical database design, data loading, or similar.
• Demonstrated SAS/SQL programming and database concepts.
• Knowledge of CDASH and SDTM standards; strong communication.
• Ability to influence without authority and coach in matrix orgs.

Responsibilities

• Manage multiple therapeutic areas and programs.
• Oversee technology evaluations for performance improvements.
• Provide strategic direction and resource management for staff.
• Ensure SDTM deliverables meet quality and regulatory standards.
• Mentor staff and drive continuous process improvements.

Skills

SAS programming

SQL programming

Data modeling

Analytical skills

Education

Bachelor's degree

Master's preferred

Tools

CDASH standards

SDTM standards

Job 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, Xand YouTube.

AbbVie 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.

Responsibilities

• Manage multiple TA
• Manage 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 expectation

• Bachelor’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 processes
• Demonstrated 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 skills

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

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https://www.abbvie.com/join-us/reasonable-accommodations.html