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Medical Standards Manager

.pre {white-space: pre-wrap;} Your tasks and responsibilities

The primary responsibilities of this role, Medical Standards Manager (MSM), are to:

  • Account for developing one or more of the following data standards governance components:
    • Data collection/processing objects (CRFs, edit checks, CCGs, reports, reference manuals/documentation);
    • Governance operations (approval process, harmonization across TA's and usage, maintenance of data standards);
    • Manage metadata standards and tools to achieve excellence in end-to-end standardization;
    • Provide technical expertise in the establishment of end–to-end data standards in area of focus of standards components and supports the process for implementation of end-to-end global standards for outputs;
    • Manage a centralized up-to-date location/portal to house standards/links/tools to standards/communications to ensure the most current standards versions are available for use and are transparent to teams;
    • Lead the standardization activities to effectively have program and study teams implement standards into their programs and studies. Liaise with the main stakeholders (GCL, ECL, Lead ME, PST, PDM) to convert a medical concept into a standard object blueprint;
    • Drive communication and training of data standards and process to ensure harmonization cross TA's and maintain single portal housing/linkages to current standards.

 

.pre {white-space: pre-wrap;} Who you are

Your success will be driven by your demonstration of our LIFE values.  More specifically related to this position, Bayer seeks an incumbent who possesses the following:

 

Required Qualifications:

  • B.S. degree in Life Sciences, Computer Science, Mathematics, Medical Informatics, Statistics, Public Health, or Biology;
  • 8 years of experience of Pharma, CRO, Life Science in Data Analytics or related fields experience with specific experience of producing Key Performance Indicators in building statistical models for addressing business issues;
  • Strong knowledge of multiple core Clinical Development functions (data management, statistical programming, medical writing, trial management and monitoring);
  • Deep understanding of the drug development processes including the relevant regulations and industry standards;
  • Proven track record of successful leadership of teams or groups in a diverse setting;
  • Strong knowledge of developing architecture and specifications;
  • Excellent communication and negotiation skills and high credibility;
  • Strong analytical, planning and organizational skills.

 

Preferred Qualifications:

  • M.S. degree in Life Sciences, Computer Science, Mathematics, Medical Informatics, Statistics, Public Health, or Biology;
  • Medical degree combined with broad understanding of the clinical development process would be a plus.
.pre {white-space: pre-wrap;} Your application Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.