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Senior Clinical Trial Disclosure Manager

hace 2 meses

Barcelona, Barcelona, España Bayer A tiempo completo
About the Role

Bayer is a leading global healthcare company, driven by a vision to make a difference in the lives of people and the world around us. We're seeking a highly skilled and experienced Senior Clinical Trial Disclosure Manager to join our team.

Key Responsibilities
  • Manage and publicly disclose 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.
  • Analyze cross-functional internal requirements and the rapidly changing external legal and regulatory requirements, industry commitments, and obligations to further develop and continuously update Bayer's disclosure strategy for clinical trial information.
  • Disclose information on Bayer's Clinical Trials at a high level of quality by fully complying with the related Quality Assurance processes.
  • Contribute to the further development and implementation of related Quality Assurance processes.
Scope

This role will be responsible for:

  • Collection and supervision of the necessary data for public disclosure of clinical trial information within Bayer.
  • Designing forms/templates, requesting information, tracking responses, and disclosing information.
  • Managing provision and providing up-to-date and consistent Clinical Trial Posting data on all required company-owned and public websites.
  • Performing and supervising quality control of publicly disclosed clinical trial information according to the QA process established.
  • Checking consistency of disclosed information for a study, including consistency of disclosed information on different internet sites and of registry and results posting information for the same study.
  • Checking postings for inappropriate wording, especially for promotional language.
  • Complying with internal disclosure processes and external legislations and obligations.
Key Contact Relations

The position holder will directly interact with:

  • Study and Project teams.
  • Global Development Therapeutic Area Heads.
  • Global Study Management Head.
  • Global Regulatory Affairs Therapeutic Area Heads.
  • Other Development/MA/PV and CH Senior Managers.
Qualifications & Competencies
  • Advanced degree in Medicine, Life Sciences, or Natural Sciences or equivalent long-term professional experience.
  • Minimum 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 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.
  • Good ability to manage resources smartly and to do things simply and effectively.
  • Good ability to think and act with customers in mind.
  • Good ability to overcome complexity and to provide oversight.