Clinical Trial Posting Expert

hace 6 meses

Barcelona, España Bayer A tiempo completo

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.

Clinical Trial Posting Expert 

Purpose:

• Supervise, manage and publicly disclose clinical trial information into clinical trial registries and disclosure 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
• Manage 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
• Support a sound understanding of the legally mandated Clinical Trial Disclosure processes of all involved functions, manage and provide training of the involved departments where required
• Disclose information on Bayer’s Clinical Trials at high level quality by fully complying to the related Quality Assurance processes
• Manage 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 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
• Manage 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 working relations:

Position holder directly interacts with the R&D Leadership Team, the Heads of Clinical Development and Clinical Operations functions including Consumer Health, the MA&PV Leadership Team as well as other involved Bayer departments like the Legal department, Patents department, Corporate Communications, and Head of Investor Relations of Bayer AG.

Qualifications & Competencies:

• Graduate level in Medicine, Life Sciences, or Natural Sciences or equivalent long-term professional experience
• Min. 3 - 5 years experience in clinical trial disclosure with significant experience related to the conduct and analysis of clinical trials
• 1-2 year working experience as ‘Senior Clinical Trial Posting Manager’, or equivalent professional experience in Trial Disclosure
• Very advanced, thorough understanding of global legislations, regulations and guidelines; Strong ability to understand and comply to complex legislations and regulations
• Profound understanding of ICH/GCP regulations

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