System Design Analyst II-Clinical Systems- HYBRID

Allergan; Irvine (CA); On-site; USD 120,000 - 160,000; Full time

Job summary

AbbVie Data Science in Irvine seeks a seasoned professional to drive standardization and delivery of clinical data systems. You will design and implement EDC-based solutions, ensuring compliance with CDASH/SDTM and regulatory guidelines.

With 5+ years in EDC environments, you will mentor teams, influence stakeholders, and coordinate across study teams to ensure on-time delivery and data integrity. This role offers opportunities to shape global data standards and drive process improvements.

Qualifications

• Bachelor’s degree in business, MIS, CS, life sciences or equivalent; Masters preferred.
• 5+ years of hands-on technical Study build in EDC; Medidata RAVE experience required; Veeva EDC a plus.
• Deep knowledge of clinical trial processes.
• Strong CDASH and SDTM knowledge.
• Proven ability to influence others and coach in a matrixed environment.
• Excellent communication and analytical skills.

Responsibilities

• Develop common data standards and ensure designs comply with standards and protocol requirements.
• Design and develop clinical trial systems with optimal functionality and data flow.
• Maintain TA- and program-level consistency across design work.
• Deliver on-time design and delivery of new clinical systems and integrations.
• Collaborate with CDO and cross-functional teams to align objectives.

Skills

Clinical trial knowledge

Influence without authority

Mentoring/coaching

Communication skills

Analytical skills

Education

Bachelor’s degree or equivalent

Master's degree preferred

Tools

Medidata RAVE

Veeva EDC

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

Purpose:

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 study-level accountabilities assigned to Clinical Data Strategy Organization.

Responsibilities:

• Actively participates in the development of common data standards and ensures systems designs comply with the standards, as well as with associated protocol requirements. Ensures that the design team utilizes standards
• Establishes and maintains methodology used by the team to design and develop clinical trial systems, benchmarking against industry standards. Ensures that systems are specified to optimize functionality, end user experience, and data flow. Ensures that the design team meets these expectations
• Ensures that TA- and program-level consistency is achieved by the design team
• Accountable for the on-time design and delivery of new clinical systems, integrations between systems, as well as any required changes to clinical systems (e.g., EDC, IRT, ePRO). Utilizes project management tools to track study progress and plan work. Anticipates and identifies issues that could affect timelines or quality and develops options and solutions
• Interacts with and influences CDO and cross-functional team members to achieve program and study objectives. Ensures that assigned work product is synchronized with upstream and downstream dependencies
• Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and functional quality standards. Stays abreast of new and/or evolving local regulations, guidelines and policies related to clinical development
• Responsible for coaching and mentoring members of the team, as well as contributes to their skill development
• Leads CDO and cross-functional innovation and process improvement initiatives

Qualifications

• Bachelor’s degree in business, management information systems, computer science, life sciences or equivalent. Masters preferred.
• Must have 5+ years of hands-on technical Study build in EDC. Experience with technical study build in Medidata RAVE is required. Veeva EDC technical study build experience is a plus.
• In-depth knowledge of clinical trial processes.
• In-depth knowledge of CDASH (Required) and SDTM.
• Demonstrated performance as a key contributor to initiatives and advancement of the organization.
• Demonstrated ability to influence others without direct authority. Demonstrated ability to successfully coach / mentor in a matrixed environment. Demonstrated effective communication skills and analytical skills.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal 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 thetimeofthis posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographiclocation,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 toparticipatein our short-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.Theamountandavailabilityof anybonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company'ssoleandabsolutediscretion unless and until paid andmay bemodifiedat the Company’s sole and absolute discretion, consistent withapplicable 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

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