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Data Management Expert, Early Clinical Development x 3

Location Gaithersburg, Maryland, United States Gothenburg, Västra Götaland County, Sweden Royston, England, United Kingdom Wilmington, Delaware, United States Job ID R-062266 Date posted 01/31/2020

Data Management Expert, Early Clinical Development x 3

Cambridge, Wilmington, Gaithersburg or Gothenburg

At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality.

Data management Expert is responsible for oversight of the delivery of high quality clinical data management via external partners. To maintain a constant awareness of trends/changes in external DM strategies and technologies and advise management on areas of improvement.

Main Duties and Responsibilities

  • Data management vendor and appropriate documentation oversight.
  • Data management expertise in supporting strategic, operational and standards aspects of Data Management.
  • Review, assess and manage DM delivery of relevant performance measures and drive continuous improvement.
  • Strategic input to DM activities within and across therapeutic areas and ensure study teams utilize data collection standards.
  • Lead, coordinate and ensure transparency and consistency of project, study and partner activities including providing partners with AZ project planning information (scheduling of the studies, volumes, timelines etc.).
  • Provide input into the DM related activities associated with regulatory inspections/audits in liaison with Clinical Quality Assurance.
  • Work with external partners providing input into the production of the service orders and study costs for data management services where needed.
  • Specialist in TA specific data capture and standards (Oncology, respiratory and cardiovascular) and CDISC standards. 
  • Provide leadership to the delivery of components of technical programming and information for a project.
  • Identify opportunities to improve the methodology and provide practical solutions for problems.
  • Support DQM’s and any other members within ECD as required.

Minimum Requirements

  • Bachelor’s degree in the life science, related subject or relevant experience.
  • Extensive experience from within the pharmaceutical industry or clinical research organization.
  • Demonstrated comprehensive knowledge and experience of aspects of Data Management
  • Excellent Communication skills
  • Comprehensive knowledge of clinical data standards.
  • Comprehensive knowledge of database structures and of capturing and storing clinical information.
  • A collaborative mind-set.
  • The ability to drive innovations.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

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Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.