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 study-level accountabilities assigned to Data and Statistical Sciences.

Responsibilities

• Uses understanding of clinical trial concepts and cross-functional protocol requirements to execute assigned study assignments
• Engages with members of the DSS and cross-functional study teams in order to effectively execute assigned activities
• Effectively utilizes available technology to execute assigned activities
• Develops and utilizes data standards (e.g. CDASH and SDTM) and protocol requirements in the design and development of key system interfaces and end-to-end data flow
• Creates study execution documentation including specifications data management plan and integrated data review plan. Executes data management plan and integrated data review plan as required by protocol and team decisions
• Triages issues as they occur and maintains required documentation per ALCOA principles. Performs data review using supplied data review tools. Performs reconciliation of data originating from different sources. Queries clinical sites as necessary to clarify possible data abnormalities
• If assigned may lead process improvement efforts within Data and Statistical Sciences. May be assigned indirect reports during the execution of projects
• Utilizes operational data and analytical tools to optimize execution of assigned clinical trials and to identify key areas of risk that may require escalation
• Mentors junior team members
• 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 :

• Bachelors degree in business management information systems computer science life sciences or equivalent. Masters preferred
• Must have at least 4 year of pharmaceutical clinical research data management health care or other relevant experience
• Strong understanding of clinical trial processes and clinical technology
• Demonstrated history of successful execution in a fast-paced environment and in managing multiple priorities effectively
• Demonstrated leadership traits and the ability to coach/lead in a matrix environment
• Strong understanding of GCDMP
• Demonstrated effective communication skills
• Demonstrated effective problem-solving and 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. 

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:

No

Employment Type :

Full-time

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