Senior EDC Lead

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          "text": "<p>Purpose:</p><p>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.&#xa0; This role is key to ensuring successful delivery against the program- and study-level accountabilities assigned to Clinical Data Strategy Organization.&#xa0;&#xa0;&#xa0;&#xa0;&#xa0;&#xa0;&#xa0;</p><p>Responsibilities:</p><p>•Actively participates in the development of common data standards and ensures systems designs comply with the standards, as well as with associated protocol requirements.&#xa0; Ensures that the design team utilizes standards</p><p>•Establishes and maintains methodology used by the team to design and develop clinical trial systems, benchmarking against industry standards.&#xa0; Ensures that systems are specified to optimize on functionality, end user experience, and data flow. Ensures that the design team meets these expectations</p><p>•Ensures that TA- and program-level consistency is achieved by the design team</p><p>•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).&#xa0; Utilizes project management tools to track study progress and plan work.&#xa0; Anticipates and identifies issues that could affect timelines or quality and develops options and solutions</p><p>•Interacts with and influences CDO and cross-functional team members to achieve program and study objectives.&#xa0; Ensures that assigned work product is synchronized with upstream and downstream dependencies</p><p>•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.&#xa0; Stays abreast of new and/or evolving local regulations, guidelines and policies related to clinical development</p><p>•Responsible for coaching and mentoring members of the team, as well as contributes to their skill development</p><p>•Leads CDO and cross-functional innovation and process improvement initiatives</p>",
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          "text": "<p>•Bachelor’s degree in business, management information systems, computer science, life sciences or equivalent.&#xa0; Masters preferred.</p><p>•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.</p><p>•In-depth knowledge of clinical trial process.</p><p>•In-depth knowledge of CDASH (Required) and SDTM.</p><p>•Demonstrated performance as a key contributor to initiatives and advancement of the organization.</p><p>•Demonstrated ability to influence others without direct authority.&#xa0; Demonstrated ability to successfully coach / mentor in a matrixed environment.&#xa0; Demonstrated effective communication skills and analytical skills.</p>",
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          "text": "<p><strong>About AbbVie</strong></p><p>AbbVie'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 AbbVie, please visit us at&#xa0;<a href=\"http://www.abbvie.com/\" rel=\"noopener noreferrer\">www.abbvie.com</a>. Follow @abbvie on&#xa0;<a href=\"https://www.linkedin.com/company/abbvie/\" rel=\"noopener noreferrer\">LinkedIn,</a>&#xa0;<a href=\"https://www.facebook.com/AbbVieGlobal/\" rel=\"noopener noreferrer\">Facebook</a>,&#xa0;<a href=\"https://www.instagram.com/abbvie/\" rel=\"noopener noreferrer\">Instagram</a>,&#xa0;<a href=\"https://twitter.com/abbvie\" rel=\"noopener noreferrer\">X</a>&#xa0;and&#xa0;<a href=\"https://www.youtube.com/user/AbbVie\" rel=\"noopener noreferrer\">YouTube.</a></p>",
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          "text": "<p>Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or&#xa0;local law:&#xa0;​</p><ul><li><p>The compensation range described below is the range of possible base pay compensation that the Company&#xa0;believes in&#xa0;good faith it will pay for this role at &#xa0;the&#xa0;time&#xa0;of&#xa0;this posting based on the job grade for this position.&#xa0;Individual&#xa0;compensation paid within this range will depend on many factors &#xa0;including &#xa0;geographic&#xa0;location,&#xa0;and&#xa0;we&#xa0;may ultimately&#xa0; pay more or less than the posted range. This range may be&#xa0;&#xa0;modified in the&#xa0;future.&#xa0;​</p></li><li><p>We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),&#xa0;medical/dental/vision&#xa0;insurance and 401(k) to eligible&#xa0;employees.​</p></li><li><p>This job is eligible to&#xa0;&#xa0;participate in our short-term incentive&#xa0;programs.&#xa0;​</p></li></ul><p>Note: No amount of pay&#xa0;is&#xa0; considered to be&#xa0;wages or compensation until such amount is earned, &#xa0;vested, &#xa0;and&#xa0;determinable.&#xa0;The&#xa0;amount&#xa0;and&#xa0;availability&#xa0;of &#xa0;any&#xa0;bonus,&#xa0;commission, incentive, benefits, or any other form of&#xa0;compensation and benefits&#xa0;that are allocable to a&#xa0; &#xa0;particular employee&#xa0;&#xa0;remains in the Company's&#xa0;sole&#xa0;and&#xa0;absolute&#xa0;discretion unless and until paid and&#xa0;may be&#xa0;&#xa0;modified at the Company’s sole and absolute discretion,&#xa0; consistent with&#xa0;applicable law.&#xa0;​</p><div sr-tagline=\"\"></div><p>AbbVie 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.&#xa0;</p><p>US &amp; Puerto Rico only - to learn more, visit&#xa0;<a href=\"https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html\" rel=\"noopener noreferrer\">https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html</a></p><p>US &amp; Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:</p><p><a href=\"https://www.abbvie.com/join-us/reasonable-accommodations.html\" rel=\"noopener noreferrer\">https://www.abbvie.com/join-us/reasonable-accommodations.html</a></p>",
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