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.
List up to 10 main responsibilities for the job. Include information about the accountability and scope.
- The IRT Lead partners with internal team members to ensure the study protocol necessities are represented in Statement of Work (SOW) and Study Design Requirement documents.
- Collaborate with team members to ensure various IRT integrations are properly designed.
- He or she is accountable to work with the IRT vendor to ensure that study design, amendments, and timelines are successfully achieved.
- Experience with authoring IRT Requirements
- Experience with interpreting and incorporating protocol needs IRT into study documents
- Experience with authoring User Acceptance Test (UAT) scripts based on the details included in the study protocol, input from the study team, and Study Design Requirements.
- Support live studies where protocol amendments, questions, or escalations may need to be addressed. The Lead will be responsible for collaborating with the team and the IRT vendor to determine next steps.
- Expected to share IRT technical expertise with the study team, future study teams, and department to ensure lessons learned and standards are continuously improved and implemented.
- Participate in department and cross department initiatives to ensure the clinical trial experience continues to improve
- The Lead must have strong communication, team building, excellent problem-solving, critical thinking skills in order to provide the team an optimal IRT system.
- Serve as an IRT subject matter expert in the various interactions with the study team, IRT vendor, and department team members.
- Ensure IRT best practices, standards, and common data standards are incorporated into the study build and live study maintenance.
- 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.
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. Masters preferred. In depth clinical trial experience. An understanding of IRT concepts and standard processes such as but not limited to, resupply, protecting the study blind, randomization, and data standards. Must have 3+ years of clinical technology experience with IRT, clinical supply or 5+years of experience in a similar technical role or in a clinical development role. Experience with common industry design and development tools preferred. Project Management and/or continuous improvement experience. Comfortable working in a matrix and global team environment.
Demonstrated understanding of clinical trial process
Demonstrated ability to influence of others without direct authority
Demonstrated effective communication skills
Demonstrated effective analytical skills
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.