Job Details

Company Description

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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) .

Job Description

AbbVie Clinical Data Strategy & Operations (CDSO) 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 of clinical systems against the program and

study level accountabilities assigned to Data and Statistical Sciences (DSS).

• As the Clinical Data Systems Lead, accountable for the on-time design and delivery of the clinical systems across the assigned portfolio

• Utilizes effective project management tools to track study progress and plan work.

• Proactively identifies issues that could affect timelines or quality and develops options and solutions

• Ensures study team needs are executed as per their requirements and reflected in design documents and clinical data standards (CDASH, SDTM etc.) and Protocol, are adhered to.

• Ensures that systems are specified to optimize on functionality, end user experience, and data flow along with Therapeutic Area (TA) and program level consistency is achieved

• Interacts with and influences DSS and cross-functional team members to achieve program and study objectives. Ensures that assigned work product is synchronized with upstream and downstream technology, process, and data flow dependencies

• Leads Clinical Data Strategy & Operations technology innovation and process improvement initiatives and may participate in broader CDSO initiatives that impact Data and Statistical Science and cross-functional study teams

• Works with the clinical system vendors for various technologies to support study portfolio

• Understands documentation and regulatory requirements to support inspection readiness

• Coaches and mentors Clinical Technology Strategy & Operations Associates

• Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and to functional quality standards. Stays abreast of new and/or evolving local regulations, guidelines and policies related to clinical development

Qualifications

• Bachelor’s degree in business, management information systems, computer science, life sciences or equivalent. Masters preferred

• Must have 5+ years of diverse clinical and healthcare technology experience in clinical data collection, processing, analytics, and project management.

• Hands on Deep Technical Expertise with common industry design and development tools Medidata

• RAVE (5+years) and Veeva EDC (2+years) required

• Custom Function Expertise Preferred

• Demonstrated understanding of the clinical trial process

• Knowledge of CDASH and SDTM

• Demonstrated performance as a key contributor to initiatives and advancement of their organization

• Demonstrated ability to influence others without direct authority and deep collaboration skills. Demonstrated effective communication skills - verbal, written.

• 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 Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. ?

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.?

• This job is eligible to participate in our short-term incentive programs. ?

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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 employee 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

Salary: $82,500 - $157,500