Senior EDC Lead

Purpose

Abb Vie 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 Clinical Data Strategy Organization.

• Actively participate in the development of common data standards and ensure systems designs comply with the standards and protocol requirements.
• Establish and maintain methodology used by the team to design and develop clinical trial systems, benchmarking against industry standards. Ensure that systems are specified to optimize functionality, end‑user experience, and data flow.
• Ensure that the design team meets expectations and that TA‑ and program-level consistency is achieved.
• Accountable for the on‑time design and delivery of new clinical systems, integrations between systems, and any required changes to clinical systems (e.g., EDC, IRT, ePRO). Utilize project management tools to track study progress and plan work, anticipating and identifying issues that could affect timelines or quality and developing options and solutions.
• Interact with and influence CDO and cross‑functional team members to achieve program and study objectives. Ensure that assigned work product is synchronized with upstream and downstream dependencies.
• Ensure adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, Abb Vie Standard Operating Procedures (SOPs), and functional quality standards. Stay abreast of new and evolving local regulations, guidelines, and policies related to clinical development.
• Coach and mentor members of the team, contributing to their skill development.
• Lead CDO and cross‑functional innovation and process improvement initiatives.

• Bachelor's degree in business, management information systems, computer science, life sciences or equivalent;
  Master’s preferred.
• 5+ years of hands‑on technical study build experience in EDC; experience with Medidata RAVE is required. Veeva EDC technical study build experience is a plus.
• In‑depth knowledge of clinical trial processes, CDASH (required), and SDTM.
• Demonstrated performance as a key contributor to initiatives and advancement of the organization.
• Demonstrated ability to influence others without direct authority, coach/mentor in a matrixed environment, and effectively communicate and analyze.

• 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. This range may be modified in the future.
• Comprehensive benefits package including paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) for eligible employees.
• This job is eligible to participate in our short‑term incentive programs.

Abb Vie 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 – for more information, visit

US & Puerto Rico applicants seeking a reasonable accommodation can learn more at