Senior Clinical Trial Disclosure Manager
hace 4 días
About Bayer
We're a global leader in the life sciences industry, driven by a vision to make a difference in the world.
Our Mission
We strive to create innovative solutions that improve human health and well-being, while also protecting the environment and promoting sustainable development.
Job Summary
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, including regular updates and maintenance of the disclosed information according to internal and external requirements.
- Analyze the cross-functional internal requirements and the rapidly changing external legal and regulatory requirements, industry commitments and obligations to further develop and continuously update of Bayer's disclosure strategy for clinical trial information.
- Disclose information on Bayer's Clinical Trials at high level quality by fully complying to the related Quality Assurance processes.
- Contribute to further development and implementation of related Quality Assurance processes.
Scope
Global
Key Skills and Qualifications
- 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.
- 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.
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