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:

•The EDC Lead Ensures that the requirements of each study protocol are reflected in EDC systems designs(Veeva EDC/ Medidata RAVE) and that common data standards(CDASH/SDTM) are used effectively

•Accountable for the High Quality, CDASH Conformance, on-time design and delivery of new clinical systems, integrations between systems, as well any required changes to EDC clinical systems.  Utilizes project management tools to track study progress and plan work.  Anticipates and identifies issues that could affect timelines or quality and develops options and solutions

• Proven ability to manage more complex study protocols

Ensures that systems are specified to optimize on functionality, end user experience, and data flow

Ensures that the eCRF design best practice and EDC best practices are adhered to

Participate in the creation of standards, either through tools, libraries or processes, as required to ensure efficient, effective and optimal processes.

Develop, improve and implement project specific tools

•Ensures that 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 dependencies

•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

•Responsible for coaching and mentoring Data Science Associates

•Participates in DSS and cross-functional innovation and process improvement initiatives

Improve upon industry knowledge and best practices.

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

•Must have 5+ years of clinical technology experience (e.g., EDC, IRT, ePRO) or 7+ years of experience in a similar technical role or in a clinical development role.  Experience with common industry design and development tools preferred. Veeva EDC Expertise Preferred, Medidata RAVE Expertise a plus

•Demonstrated understanding of clinical trial process

•Knowledge of CDASH and SDTM

•Collaborative and Proactive

Demonstrated ability to influence of others without direct authority

•Demonstrated effective communication skills

•Demonstrated effective analytical skills

AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.