Senior Clinical Trial Disclosure Manager

hace 3 semanas

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

Bayer is a global leader in the life sciences industry, and we're committed to making a positive impact on people's lives. We're seeking a highly skilled and experienced Senior Clinical Trial Disclosure Manager to join our team.

Job Summary:

The Senior Clinical Trial Disclosure Manager 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
  • Contribute to continuous monitoring for changing and new Clinical Trial Posting requirements to keep the Global Development Management up to date and to adjust and update the global strategy and internal rules and processes accordingly

Requirements:

  • Advanced degree in Medicine, Life Sciences, or Natural Sciences or equivalent long-term professional experience
  • At least 3 years of 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 with 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 RD functions and other internal customers
  • Advanced written and oral communication skills
  • 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're a motivated and experienced professional looking for a new challenge, we encourage you to apply for this exciting opportunity.

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