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Lead Clinical Technology Analyst

Employer
AbbVie
Location
Lake County, IL, US
Start date
Jul 16, 2019

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Discipline
Clinical, Clinical Research
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
BioMidwest, Best Places to Work
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Job Details

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

Key Responsibilities Include :
  • Develops, with close partnership, the DSS technology strategy. Performs landscape analyses to determine viable technology options and to map short-, mid- and long-term solution options. Executes proof-of concept work to test potential technology solutions. Assesses new technologies in collaboration with IT,technology partners, vendors and TQM. Aligns DS technology and process to optimize against the defined strategy
  • Defines and connects standards to optimize clinical data flow from collection to analysis-ready datasets. Utilizes available technology to design mappings of source data structures to fit-for-purpose data models (e.g., SDTM, data review). Ensures traceability of data through the systems pathway.
  • Works with cross-functional stakeholders to define mHealth (e.g., PRO, wearables, sensors) processes, collection requirements, as well as cleaning and storage solutions
  • Engages and leads global functional and cross-functional teams including IT and technology specialists from peer organizations. Ensures that DSS tech strategy aligns with pharmaceutical development and enterprise strategies. Also aligns with business process owners
  • Participates in oversight of vendors and provides feedback related to clinical trial operations, issues and trends in performance
  • Responsible for coaching and mentoring technology colleagues, as well as providing input into their development. May include direct/indirect supervision of staff, as well as supervision of the work of contract resources
  • Leads cross-functional innovation and process improvement initiatives. Responsible for identifying training needs and standardizing and facilitating training solutions for DS roles
  • 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.
  • Acts as the clinical data systems SME during regulatory inspections and internal quality audits


  • Bachelor's degree in business, management information systems, computer science, life sciences, engineering or equivalent. Master's preferred
  • 6+ years of pharmaceutical, clinical research, data management, health care technology experience or 8+ years of broader technology experience
  • In-depth understanding of clinical trial process and clinical technology
  • Demonstrated performance as a cross-functional leader
  • Demonstrated deep understanding of the clinical development process, including supporting technology
  • Demonstrated ability to lead successful initiatives at the organizational, cross-organizational and global levels
  • Excellent communication skills
  • Excellent problem-solving and analytical skills
  • Ability to interface and influence at all levels in the organization
  • Demonstrated strategy development and execution skills Demonstrated knowledge of multiple technology domains and the associated dependencies

Company

AbbVie’s mission is to discover and deliver innovative medicines 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: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, and YouTube.

Stock Symbol: ABBV

Stock Exchange: NYSE

Company info
Website
Phone
1-800-255-5162
Location
1 North Waukegan Road
 North Chicago
Illinois
60064
US
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