At Bayer, we’re visionaries driven to solve the world’s toughest challenges, striving for a world where 'Health for all, Hunger for none' is no longer just a dream but a reality. We approach this with energy, curiosity, and dedication, learning from diverse perspectives, expanding our thinking, and redefining what’s possible. If you’re eager to build a meaningful career in a community of brilliant, diverse minds to make a real difference, Bayer is the place for you.
Clinical Trial Posting Expert
Purpose :
- Supervise, manage, and disclose clinical trial information on registries and websites according to internal rules and external regulations across Bayer’s product portfolio, ensuring regular updates and maintenance.
- Manage internal requirements and external legal and regulatory obligations to develop and update Bayer’s clinical trial disclosure strategy.
- Support understanding of clinical trial disclosure processes, provide training to involved departments as needed.
- Disclose clinical trial information with high quality, fully complying with Quality Assurance processes.
- Develop and implement related Quality Assurance processes.
Scope : Global
Key tasks :
- Collect and supervise data necessary for public disclosure, design forms/templates, request information, track responses, and disclose information.
- Ensure provision of up-to-date, consistent clinical trial data across all websites.
- Perform and oversee quality control of disclosed information according to QA processes.
- Check for consistency of information across sites and registry data.
- Review disclosures for appropriate wording, avoiding promotional language.
- Ensure compliance with internal processes and external legislations.
- Monitor evolving disclosure requirements and update strategies and processes accordingly.
Key working relations :
The position involves direct interaction with R&D Leadership, Clinical Development and Operations heads, MA&Pv Leadership, Legal, Patents, Corporate Communications, and Investor Relations departments.
Qualifications & Competencies :
- Graduate in Medicine, Life Sciences, or Natural Sciences, or equivalent professional experience.
- At least 3-5 years of experience in clinical trial disclosure, with significant trial conduct and analysis experience.
- 1-2 years in a senior clinical trial posting or trial disclosure role.
- Deep understanding of global legislations, regulations, and guidelines; ability to interpret and comply with complex legal requirements.
- Profound knowledge of ICH / GCP regulations.