Senior Manager, Clinical Data Systems

ABBVIE; Irvine (CA); On-site; USD 125,000 - 237,000; Full time

Job summary

AbbVie in Irvine, CA is seeking a senior data science leader to drive clinical trial data delivery and operational excellence within the Data Science group. You will lead cross-functional teams and oversee vendor performance to ensure timely, high-quality SDTM/CDASH deliverables.

The role emphasizes staff development, process improvement, and strategic guidance to sustain a high-performing organization in a fast-paced therapeutic area.

Qualifications

• Bachelor’s degree in MIS/CS/life sciences or equivalent. Master’s preferred.
• 8+ years experience with clinical DB design, data loading, and data modeling; or 9+ years in a similar environment.
• Intermediate SAS and/or SQL programming; expert database concepts.
• In-depth CDASH/SDTM knowledge; understanding of clinical trial processes.
• Ability to influence without authority; proven coaching in matrix environments; strong communication & analytical skills.

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 performance assessment responsibilities for direct reports; training, feedback and retention.
• Manage cross-functional initiatives.
• Provide strategic direction, advice and guidance to staff on operations; promote best practices.
• Oversee vendor deliverables and SDTM quality and regulatory requirements.

Skills

SAS

SQL

Analytical skills

Communication skills

Mentoring

Education

Bachelor’s degree in MIS/CS/life sciences or equivalent

Master’s degree preferred

Tools

CDASH

SDTM

Database concepts

Job description

• Compensation: USD 124,500 - USD 236,500 - yearly

Company 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 Description

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

Qualifications

• 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

Additional Information

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.

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