Senior Clinical Trial Disclosure Specialist

hace 2 semanas

Barcelona, Barcelona, España Bayer A tiempo completo
Job Title: Senior Clinical Trial Disclosure Specialist

Bayer is a leading global healthcare company that is committed to making a positive impact on people's lives. We are seeking a highly skilled and experienced Senior Clinical Trial Disclosure Specialist to join our team.

Job Summary:

The Senior Clinical Trial Disclosure Specialist will be responsible for managing and publicly disclosing clinical trial information into clinical trial registries and posting of clinical trial result summaries on company-owned and public international websites. This includes regular updates and maintenance of the disclosed information according to internal and external requirements.

Key Responsibilities:

  • Collection and supervision of the necessary data for public disclosure of clinical trial information within Bayer
  • Manage provision/provide up to-date and consistent Clinical Trial Posting data on all required company-owned and public websites
  • Perform and supervise quality control of publicly disclosed clinical trial information according to the QA process established
  • Check consistency of disclosed information for a study, i.e., consistency of disclosed information on different internet sites and of registry and results posting information for the same study
  • Check postings for inappropriate wording, especially for promotional language
  • Check compliance to internal disclosure process and to external legislations and obligations

Requirements:

  • Advanced degree in Medicine, Life Sciences, or Natural Sciences or equivalent long-term professional experience
  • Min years experience in clinical trial disclosure with significant experience related to the conduct and analysis of clinical trials
  • Advanced understanding of global legislations, regulations, and guidelines; Strong ability to understand and comply to complex legislations and regulations
  • Advanced understanding of ICH/GCP regulations
  • Advanced understanding of drug development process over different stages
  • Advanced understanding of IT processes and Systems used in Clinical Development, especially Clinical Trial Management Systems, Document and Workflow Management Systems
  • Strong skills in English language, both oral and written (fluent speaking mandatory)
  • Advanced knowledge of the Bayer product and development portfolio
  • Solid understanding of cross-divisional business requirements of R&D functions and other internal customers
  • Advanced written and oral communication skills; Advanced understanding of Bayer's general communication policy to the public, to Health Authorities and to Regulatory Bodies
  • Advanced project management and project leadership skills

What We Offer:

Bayer offers a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and experienced professional looking for a new challenge, please submit your application.

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