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Location:
Gaithersburg, Maryland, United States
Shanghai, Shanghai Municipality, China
Warsaw, Mazovia, Poland
Job reference: R-030803
Posted date: Sep. 24, 2018
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Data Management Quality Leader

On-Site - Gaithersburg, MD

At AstraZeneca we believe in the potential of our people and we’ll develop you beyond what you thought possible. We make the most of your skills and passion by actively supporting you to see what you can achieve no matter where you start with us. As a Business Insights & Analytics Manager in Cambridge or Gaithersburg, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.  We work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe.

BUSINESS AREA

Our vision in Oncology is to help patients by redefining the cancer-treatment paradigm, with the aim of bringing six new cancer medicines to patients between 2013 and 2020. A broad pipeline of next-generation medicines is focused principally on four disease areas - breast, ovarian, lung and hematological cancers. As well as other tumor types, these are being targeted through four key platforms - immunotherapy, the genetic drivers of cancer and resistance, DNA damage repair, and antibody drug conjugates, underpinned by personalized healthcare and biomarker technologies. Global Medicines Development (GMD) business unit drives late-stage development of our innovative pipeline, transforming exciting science into valued new medicines and ensuring patients around the world can access them.

This is an on-site office position which can be located in any of the following primary AstraZeneca Office location: Gaithersburg, MD (local) or May consider international sites in: Warsaw,Poland or Shanghai, China. You will play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.

THE ROLE INVOLVES

  • Providing data management (DM) expertise to the study team(s) and is responsible for overseeing and managing all DM activities for the study
  • Serve as a core team member of the study team(s) and is accountable for all DM-related communications, specifications, and documentation that includes but not limited to the Data Management Plan (DMP)
  • Accountability for the overall quality and integrity of the database with respect to “Critical to Quality” (CTQ) data points predefined by Clinical and Biostat prior to the start of a study
  • Managing the Data Quality Plan to ensure CTQ data points are of the highest integrity and completeness

DAILY RESPONSIBILITIES

  • Serves as the expert in Clinical Research Data Management to provide oversight and advice to the clinical project team(s) regarding the DM activities and deliverables
  • Manages and resolves issues related to DM deliverables by developing solutions to complex problems to ensure consistency across organization
  • Provides input to the DM related activities associated with regulatory inspections/audits
  • Provide DM excellence and consultancy in the selection and use of software systems and vendors
  • Development and oversight of DM processes and standards and functional leadership:
  • Oversee quality and consistency with AstraZeneca strategies and standards across therapeutic areas
  • Works with the Standards Group to provide input into clinical project standards and processes based on industry best practices
  • Facilitates and manages valid change requests of project standards to the Standards Committee
  • Assesses AstraZeneca CRDM needs and areas of improvement and recommends changes to the operating model
  • May be asked to provide strategic DM expertise to Global Clinical Initiatives
  • Management and oversight of vendor performance.
  • Reviews, assesses and manages DM delivery against performance indicators and overall DM performance
  • Provides input into the contract process for the CRDM vendor
  • Manage timelines and deliverables for assigned studies
  • Ensures billing is accurate and forwards recommendation to payment of invoices.
  • Operational Responsibilities
  • Accountable for the execution and overall quality of DM activities and deliverables.
  • Acts as the single point of contact for all data management deliverables for the study team during the study set-up phase, responsible for the CRF design, DB specifications (including edit checks, CRF working instructions, etc.), during study conduct, and study close-out activities.
  • Provide guidance and supervision to Lead Data Managers/DM Team Leads working on the study (CRO or in-house)
  • Accountable for “real time” Data Management, ensuring that initial reviews are conducted within 5 calendar days of a patient’s data entering the EDC system, and manages the average query aging to no more than 30 calendar days.
  • Accountable for the overall quality and completeness of the Data Management Plan (DMP).
  • Responsible for working closely with the Centralized Data Monitoring group to ensure quality and integrity of our most important data points.

      SKILLS AND CAPABILITIES NEEDED

      • Education: Minimum of a BS in life sciences or computer science degree
      • 5 years or more - Strong Data Management experience in the Biotech/Pharma/CRO industry
      • 3 years or more - Focused Oncology therapeutic expertise
      • Demonstrated current understanding of GCP and regulatory requirements as they relate to data management systems and activities
      • Demonstrated current understanding of Good Clinical Data Management Practices (GCDMP)
      • Experience of clinical databases, different clinical data management systems and electronic data capture (EDC)
      • Demonstrate understanding and experience in query management process and reconciliation activities
      • Effective problem and conflict solving skills

      PREFERRED

      • Certified Clinical Data Manager (CCDM) via the Society of Clinical Data Management
      • Demonstrated knowledge of clinical and pharmaceutical drug development process
      • State of the art understanding of database structures, data standards (CDISC) and practices as they apply to CRF design, database development, data handling and reporting
      • Demonstrated understanding of clinical data system design / development / validation and system matrix

      AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. 

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      Clinical Data Management Lead (Multiple Positions)
      Project, Change, Business Improvement and Strategy Management

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