Senior EDC Lead

Abb Vie is a biopharmaceutical company whose mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow.

Abb Vie Data Science is the best‑in‑class team within its cross‑industry peer group, responsible for bringing people, process, and technology together to generate business value from clinical trials data. This role is key to ensuring successful delivery of program‑ and study‑level accountabilities assigned to the Clinical Data Strategy Organization.

• Actively participate in the development of common data standards and ensure system designs comply with the standards and associated protocol requirements, ensuring the design team utilizes the standards.
• Establish and maintain the methodology used by the team to design and develop clinical trial systems, benchmarking against industry standards, and ensuring systems are specified to optimize functionality, end‑user experience, and data flow.
• Ensure that TA‑ and program‑level consistency is achieved by the design team.
• 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), utilizing project management tools to track study progress and plan work.
• Anticipate and identify issues that could affect timelines or quality, and develop options and solutions.
• Interact with and influence CDO and cross‑functional team members to achieve program and study objectives, ensuring 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, and stay abreast of new and/or evolving local regulations, guidelines, and policies related to clinical development.
• Coach and mentor team members, 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 degree preferred.
• At least 5 years of hands‑on technical study build experience in EDC. Experience with technical study build in Medidata RAVE is required;
  Veeva EDC technical study build experience is a plus.
• In‑depth knowledge of the clinical trial process.
• In‑depth knowledge of 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.
• Demonstrated ability to successfully coach and mentor in a matrixed environment.
• Demonstrated effective communication skills and analytical skills.

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 employer remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.

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 – to learn more, visit

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