Clinical Trial Disclosure Specialist

hace 7 días

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

This role is with Bayer UK & Ireland, an inclusive employer and a member of Mygwork – the largest global platform for the LGBTQ+ business community.

Please do not contact the recruiter directly.

Bayer is a leading life science company that is committed to making a positive impact on people's lives. We are seeking a Clinical Trial Disclosure Specialist to join our team.

The successful candidate 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 based on internal rules and external guidelines, obligations, and legislations for the entire Bayer product portfolio.

The role will also involve contributing to the development and continuous update of Bayer's disclosure strategy for clinical trial information based on cross-functional internal requirements and the rapidly changing external legal and regulatory requirements, industry commitments, and obligations.

The Clinical Trial Disclosure Specialist will be responsible for disclosing information on Bayer's Clinical Trials at a high level of quality by fully complying with the related Quality Assurance processes.

Key Responsibilities:

  • Collection of the necessary data for public disclosure of clinical trial information within Bayer: design forms/templates, request information, track responses, disclose information
  • Provide up to-date and consistent Clinical Trial Posting data on all required company-owned and public websites
  • Formal quality control of publicly disclosed clinical trial information according to the QA process established
  • Check consistency of disclosed information for a study, including consistency of disclosed information on different internet sites and of registry and results information for the same study
  • Check disclosed information for inappropriate wording, especially for promotional language
  • Check compliance to internal disclosure process and to external legislations and obligations

Requirements:

  • 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 internal rules and processes accordingly

Key Relations:

  • Position holder directly interacts with Study and Project teams, with Global Development Therapeutic Area Heads, Global Study Management Head, Global Regulatory Affairs Therapeutic Area Heads, and other Development/MA/PV and CH Senior Managers

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