Senior EDC Lead

Company Description

About Abb Vie

Abb Vie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about Abb Vie, please visit us at  Follow @abbvie on Linked In, ()  Facebook, Instagram () , X ()  and You Tube.

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Job Description

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.

Responsibilities:

-Actively participates in the development of common data standards and ensures systems designs comply with the standards, as well as with associated protocol requirements.  Ensures that the design team utilizes standards

-Establishes and maintains methodology used by the team to design and develop clinical trial systems, benchmarking against industry standards.  Ensures that systems are specified to optimize on functionality, end user experience, and data flow. Ensures that the design team meets these expectations

-Ensures 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, as well any required changes to clinical systems (e.g., EDC, IRT, ePRO).  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

-Interacts with and influences CDO 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, Abb Vie 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 members of the team, as well as contributes to their skill development

-Leads CDO and cross-functional innovation and process improvement initiatives

Qualifications

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

-Must have 5+ years of hands on technical Study build 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 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 / mentor in a matrixed environment.  Demonstrated effective communication skills and analytical skills.

Additional Information

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…