IRT Associate

Purpose

Describe the primary goals, objectives or functions or outputs of this position.

 

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

List up to 10 main responsibilities for the job. Include information about the accountability and scope.

 

• Uses understanding of clinical trial concepts and cross-functional protocol requirements to execute assigned study assignments.
• General understanding and working knowledge of the Interactive Response Technology (IRT) platform
• Support more experienced IRT Leads in creating User Acceptance Testing (UAT) scripts that will effectively test the system prior to initial GoLives and Post-Production Changes
• Work with mentors to eventually create UAT scripts and support UAT activities
• Support more experience IRT Leads in creating IRT Design Specifications
• Work with mentors to eventually create IRT Design Specifications
• Support more experienced IRT Leads during Live Study Maintenance
• Work with mentors to eventually take on Live Study Maintenance activities and responsibilities
• Help assist teams with Trial Master File (TMF) and audit/regulatory inspection preparation administration
• Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and to functional quality standard. Stays abreast of new and/or evolving local regulations, guidelines and policies related to clinical development.

Qualifications

List required and preferred qualifications (up to 10). Include education, skills and experience.

 

• Bachelor’s degree in business, management information systems, computer science, life sciences or equivalent. Master’s degree preferred.
• Must have 2+ years of clinical research, analytics, life sciences or comparable experience (or) a master’s degree with no previous experience.
• Demonstrated performance as a key contributor to initiatives and advancement of their organization (academic, internships, or in a previous job).
• Demonstrated effective communication skills.
• Demonstrated history of successful execution in a fast-paced environment and in managing multiple priorities effectively.
• Demonstrated problem-solving and analytical skills.
• Demonstrated leadership traits and ability to influence others without direct authority.

At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity and affirmative action employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic. If you would like to view a copy of the company’s affirmative action plan or policy statement, please email CorpJat_ABV@abbvie.com.