Senior Manager, Clinical Data Systems

AbbVie Inc.; Irvine (CA); Hybrid; USD 150,000 - 210,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Job summary

AbbVie Data Science is seeking an experienced data leader to drive clinical data initiatives and ensure high-quality, compliant data delivery. The role combines technical oversight with people leadership to manage a team across multiple therapeutic areas.

The ideal candidate has 8+ years in clinical data, strong SAS/SQL skills, and deep knowledge of CDASH/SDTM standards, with a proven ability to mentor staff and influence stakeholders in a matrix environment.

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

Responsibilities

• Must have IRT/RSTM experience and understanding of IRT/RTSM SDLC.
• People management experience; manage multiple TAs and lead a team.
• Provide strategic direction and governance for resources and vendor management.
• Drive process improvements and optimization across the Therapeutic Area.
• Coach and mentor staff, ensure talent retention and performance management.

Skills

SAS

SQL

Education

Bachelor's degree in MIS/CS/Life sciences

Master's degree preferred

Tools

CDASH

SDTM

Job description

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,XandYouTube.

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

• Must have IRT/RSTM experience
  • Understanding of IRT/RTSM SDLC
  • IRT/RTSM Vendor Management/Governance
• Must have people management experience
• Manage multiple TAs
• Manages a team so requires former people leader experience
• 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.

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

• Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
• This job is eligible to participate in our long-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employer remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

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

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html