Senior Clinical Trial Posting Manager
hace 7 días
At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where ,Health for all, Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining 'impossible'. There are so many reasons to join us. If you're hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there's only one choice.
Senior Clinical Trial Posting Manager
Purpose:
• 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 tasks:
• Collection and Supervision of collection of the necessary data for public disclosure of clinical trial information within Bayer: design forms/templates, request information, track responses, disclose information.
• 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.
Key contact 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.
Qualifactions & Competencies:
• 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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