Senior Clinical Data Systems Lead

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 :

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.

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 Companys sole and absolute discretion unless and until paid and may be modified at the Companys 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  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more :

Work :

Yes

Employment Type : Full-time

Key Skills

Environment,Domestic,Front Desk Reception,Investment Banking,Anesthesia,Import & Export

Experience : years

Vacancy : 1